Foods Stop Constipation
R&D Productivity Pharma Biotech Industry 2011
Phase III failures and success.
After years of stagnation and declining new drug approvals and increasing R&D budgets, it seems that 2011 is going to reverse the trend. The US FDA has approved 26 new drugs by the end of August this year compared to only 21 NME approved in 2010. The current year is trending to a recent record for new drug approvals in the 35-40 range. A live updated review of R&D productivity of the pharma biotechnology industry as measured by NME approvals, Phase III success and failures and NDA/BLA filed is provided along with live RSS feeds. The FDA sends a clear message to the Industry, safety issues are important. For diet pills for slimming, long term safety and efficacy concerns must be addressed. In phase III trials, 10 positive and 11 negative results were announced. The FDA rejected Abbott filed BLA for Briakinumab for the treatment of psoriasis. The major drug failure in Phase III trials in 2011 are listed. The number of new drugs approved has remained in the 20- 25 range by the FDA during the past 4 years. The number of new drugs approved by the EMA was only 14 in 2010 a historic low in recent years. Thus despite talks of increased R&D productivity and higher R&D spending, number of new drugs clearing regulatory hurdles has remained in the 20-25 range during the past few years.Recommendations of the FDA advisory committees and listing of Complete Response Letter is provided. Approvals of existing drugs for new indications, new combinations, formulations, generics and biosimilar is not covered.
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New Drug Approvals FDA/EMA 2011
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R&D Productivity Pharma Biotech Industry 2011http://goo.gl/nzNgD.qrPart 2
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FDA Rejected Drugs (NDA/BLA) 2011
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The content dealing with Europe and EMA approvals in 2011 has been shifted to a new article
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Image of a cell undergoing mitosis 
http://www.icr.ac.uk/research/research_sections/cancer_therapeutics/cancer_therapeutics_teams/target_discovery_and_apoptosis/index.shtmlIntroduction
There is a strong need to develop safer and effective new medicines with real benefits to the patients. Comparative long term trials with placebo and active comparator drug are required. In future showing non inferiority with a existing drug may not be sufficient for approval. In cancer patients, overall survival has emerged as the primary end point for approval.Despite increased R&D budgets and spending during the 2000-2005 period by the pharmaceutical industry, the number of new drugs approved remain struck between 20-25 per year. Thus increased R&D costs failed to match the number of new drugs approved during the 1995-2000 period. Mergers andacquisition's failed to affect R&D productivity and actually led to destruction or decline. Since the past few years the R&D budgets are reduced.[1][2]
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R&DProductivity
During the past few years, the R&D budgets of major pharma and biotech companies have declined. The number of new drugs approved failed to match the increased industrial R&D budgets during the 2001-2007 period. The mergers andacquisition activity has resulted in reductions in R&D staff and positions. Current standards require long term trials in over tens of thousands patients for chronic diseases and assessment of long term safety and efficacy criteria.
FDA
FDA answers this question with a series of simple charts and graphs that show that the number of novel new drugs FDA approves each year has remained relatively steady over time. The number of new NDA/BLA for NME has decreased steadily during the past decade from a mean of 35 to 25 recently. Last year only 23 NME were filed for approval, the lowest number in the past 15 years.[3]
FDA Data http://www.fda.gov/ucm/groups/fdagov-public/documents/image/ucm243824.jpg
FDA Vs EMA
FDA answers this question with a series of charts and graphs that show that, on average, FDA has approved more novel new drugs, has approved these drugs more quickly, and has enabled these drugs to come to market sooner than has its European counterpart, the European Medicines Agency (EMA).[4].
A review of the 197 new drugs approved during 2000-2010 showed that 100 new drugs had comparative trials data with marketed drugs. Comparative data accounted for 70% of new drugs if the orphan and rare disease drugs or first approval for an indication were excluded.[5]. A Reuters report highlights the shift in clinical trials from the US and EU towards countries of Asia, Africa, Latin America and Eastern Europe accounting for 70% of the global trial patients. Trials shift is due to reduced cost, faster patient recruitment, weak regulatory and ethical oversight, dedicated clinical trial staff and availability of top local medical opinion leaders for discussions/consultations with sponsors. The problems encountered are overestimation of efficacy, underreporting of drug related adverse events, informed consent and ethical issues, high payments by local standards, loss of biological samples due to transport or red tape, kickbacks to officials etc. Lower efficacy in the US trial sites was reported for Benlysta(HGSI, GSK) for lupus and Brilinta(Astra Zeneca) for heart attacks.[6]
Free the FDA
The HHS Secretary has overruled the FDA and reversed its decision to make an oral contraceptive pill (Plan B) available to adolescent girls under 17 without prescription. There are calls in the media to make the FDA truly independent and free from political interferences.
http://www.nytimes.com/2011/12/14/opinion/free-the-fda.html
http://www.nytimes.com/2011/12/14/opinion/free-the-fda.html
Should The FDA Be Spun Out Of HHS? Matthew Herper
Forbes-39 minutes ago
The possibilities opened by this decision are frightening. A radical pro-business secretary could now, in principle, bypass the clinical trial system and the FDA approval process and decide to approve a drug.
BIO Study: Declining Drug Approvals
A recent Biotechnology Industry Organization report has highlighted the declining rates of new drug approvals.[7]
Biotechnology Industry Organization (BIO) Industry Analysis and BioMedTracker (BMT) announced results of a study today that shows the overall success rate for drugs moving through clinical trials to FDA approval from late 2003 to the end of 2010 was near one in 10. Previous reports, taken from earlier years, showed the rate of drug approvals is one in five to one in six.
The study builds on the findings from previous studies and uses a broader, deeper, and larger sample than previous reviews of clinical trials and approvals data using the BioMedTracker (BMT) proprietary database of 4, 500 drugs and over 8, 000 unique development paths. Using clinical trial data from the past seven years, the analysis examines the most recent probability of success by treatment type, phase of development and therapeutic area. Before new therapies hit the market, they have to pass a number of hurdles meeting regulatory thresholds for efficacy and safety as well as maintaining a competitive internal corporate profitability and marketability profile.
The BMT/BIO study examines the clinical Phase status of these development paths as of year-end 2003 through year-end 2010, which accounts for more than 59, 000 data points. The study determines the percentage of drugs that advance to the next Phase of development versus those that are suspended and therefore the likelihood of a drug ultimately being approved by the FDA. The data spans all companies (Big Pharma and biotechnology, both public and private) conducting development on therapeutics for approval in the U.S.
The BMT/BIO analysis includes breakdowns by indication, disease group, size of company, molecule type, route of administration, New Molecular Entity (NME) versus Biologic versus non-NME. The data encompasses the most recent data available during a time in which FDA requirements for approval have been in flux. Included in the analysis is an in-depth look at FDA decisions and approval rates by FDA review number.
Key findings from the study include:[8]
Overall success rates from Phase I to FDA approval is nearly 9%. This number is comprised of lead and secondary indications. When separated, lead indications have close to a one in seven rate of approval and secondary indications have a rate of one in 30.
Clinical Trials that address secondary Indications for drugs tend to be far less successful on average. This was seen in all phases of clinical development as well as in all disease areas.
The study also shows that large molecule drugs are twice as successful in gaining approval than small molecule drugs. New oncology drugs have the toughest time making their way through the clinic, despite cancer being the most closely studied area in drug development.
The overall success rate for drugs moving through clinical trials Phase I to FDA approval from late 2003 to the end of 2010 is near one in 10, not one in five to one in six, as previous studies analyzing older data have indicated. Access the presented study results here:BIO-BioMedTracker Study HANDOUT 2-15-2011: The Tufts University CDD data from big pharma reflects better experiencedmanagement, properresourcing the projects, experienced regulatory dealing with the FDA and getting approval. Start ups and smaller companies rush into Phase III under venture and vulture hedge funds with higher failure rates.
The BMT/BIO study examines the clinical Phase status of these development paths as of year-end 2003 through year-end 2010, which accounts for more than 59, 000 data points. The study determines the percentage of drugs that advance to the next Phase of development versus those that are suspended and therefore the likelihood of a drug ultimately being approved by the FDA. The data spans all companies (Big Pharma and biotechnology, both public and private) conducting development on therapeutics for approval in the U.S. The Tufts studylooked atthe pipelines of the 50 biggest pharmaceutical companies by sales.
Ernest and Young Beyond Borders 2011 Report[9]
The R&D investment by the biotechnology industry declined by over 20% in 2010. The number of deals and alliances between small biotech and big pharma increased but the trend was for milestones based payments. The market conditions for starts ups to raise funds.
Patent Woes Threaten Drug Firms
http://www.nytimes.com/2011/03/07/business/07drug.html?hpw
Open Source R&D Initiative
FDA Data/stats 2010
The number of INDs filed in the first 10 months last year was 418. mean 42 IND filed/monthThe number of NDAs filed in the first 10 months last year was a relatively high 69. 7 NDA filed/month
Total number of NDA/BLA, filed with NME during the past few years range 25-45 mean 30, the number of NDA filed has decreased from 45 to 25 per year.
The current listing of INDs and NDA filed per month in 2010 includes many secondary indications. A majority is mainly interested in INDs for new molecular entities for the first in man Phase I trials. The BIO recent report of probability of new drug approvals can be worked backwards to arrive at some figures. These are:
25 new drug approvals per year
The industry has to file
31 NDA/BLA
complete 56 Phase III trials with positive results
Complete 170 Phase II trials with positive outcome
Start or complete 270 Phase I trials first in man studies.
Accelerated Drug Approvals
In a review of the accelerated drug approval process for oncology drugs during the 1992 to July 2010, FDA scientists have identified some deficiencies and blamed the industry for not completing trials in time to gain regular approval. During the period, 35 cancer drugs were granted accelerated approvalsfor 47 indications. The Phase III trials were completed and confirmed in 26 indications within 7 years and 12.6 and 9.7 years in 2 cases. In 14 cases trials were not completed. Some of these drugs remained on the market >5 years and in one case >10 years. Three indications were withdrawn amifostine and gemtuzumab ozogamicin. It is suggested that the regular trials must be started before the grant of the approval, industry can be fined or cancel the program.[10][11][12][13] Dr Chabner has called for oncology drug approvals after Phase I for products like PLX4032 which show over 81% response rates. It will be unethical to give placebo to terminally ill patients when there is clear evidence of tumor regression[14][15]The current FDA gold standard for new anticancer drugs remains increase in Overall Survival (OS) in adequate number of patients, which means a few hundred depending on the tumor type. New molecular entities which work in Phase I and II often show reduced efficacy in late stage Phase III trials. Iniparib the first of the new class PARP inhibitors showed 30% response in Phase I trials and 62% in the triple negative breast cancer patients (TNBC) in Phase II trials. Iniparib when added to standard therapy increase OS by 5.5 months on average in Phase II. In phase III trials in TNBC patients, it failed to show any increase in OS. Industry has moved all the follow up PARP inhibitors to more difficult to treat ovarian cancer and bailed out of TNBC trials with these agents.We do not know which drugs passing Phase I and II will pass Phase III without doing the studies.[16]
Titled Strategic Priorities 2011 2015: Responding to the Public Health Challenges of the 21st Century, the 50-page document provides a vision of the FDA that includes:
a modernized field of regulatory science that draws on innovations in science and technology to help ensure the safety and effectiveness of medical products throughout their life cycles
an integrated global food safety system focused on prevention and improved nutrition
expanded efforts to meet the needs of special populations.
1.0Introduction
2.0Cross-Cutting Strategic Priorities
3.0Strategic Goals and Long-Term Objectives
4.0Implementation
View PDFof full document
Phase III Productivity
Phase III positive results
- Tofacitinib (Pfizer)The company announced that its new oral JAK inhibitor met its primary efficacy end point in Phase III trial in moderate to severe RA patients. The end point was ACR20 response rates at 6 months with a placebo control group. Over 4000 RA patients have been treated with the active drug. The JAK inhibitors disrupt the intracellular signaling pathwys involved in the inflammatory cytokine network. Additional indications in R&D are psoriasis, ulcerative colitis, Crohn's disease, dry eye disease and renal transplant.[17]
- Ariad ARIA reported positive Phase III data withridaforolimusin cancer of the soft tissue or bone. Jan 19
- Tarceva(erlotinib, Roche, OSI)
The data and safety monitoring committee has recommended a premature end of the EURTAC Phase III trials of Tarcevavs chemotherapy in NSCLC patients with EGFR activating mutations.The study was done in Europe. These patients had significant improvements in PFS with erlotinib.The data will be presented at ASCO2011.A similar Asian study reported at ESMO 2010, patients with EGFR expressing NSCLC had median PFS of 13.1 months vs 4.6 months with chemotherapy.A supplementalMAA was filed with EMA for first line therapy for EGFR expressing NSCLC and a filing with the FDA is planned. Tarcevais approved for second and third line therapy as well as maintenance therapy of NSCLC.[18]
- Gattex (teduglutide, NPS)-a modified GLP1, achieved its primary end point of efficacy in short bowel syndrome. Short bowel syndrome refers to poor absorption of nutrition in patients with surgical removal of small intestine due to Crohn's disease or cancer. Such patient require 12-13 litres/week of iv nutrition. In the 86 patient Phase III placebo controlled DB study, o0.05 mg/kg dose of Gattex resulted in 4.4 liter average reduction in weekly iv nutrition as compared to 2.3 liter for the placebo group. The results showed that 63% of patients treated for 24 weeks had at least a 20% reduction in for iv nutrition vs 30% patients on placebo.The drug works by increasing nutritional absorption, production of intestinal lining, slowing down gut transition and increasing blood flow. NPS plans to file for apprval in mid 2011 and nycomed has international marketing rights.
- Zealand Pharma and Sanofi Aventis announced positive Phase III data with the GLP analoguelixisentanidewhich came out better than Byetta ( exenatide) in fewer hypoglycemic events (8 vs 48 events)and non inferiority in glycemic control. Sanof Aventis had acquired global marketing rights for $ 335 million.[19]
Avastin
In Phase III trials in ovarian cancer, met the primary efficacy end point by extending overall survival when added to the chemotherapy. MAA filed in Europe, BLA filing due in the US.
Arcalyst (rilonacept, Regeneron) The interleukin I trap met its primary end point of efficacy in reducing flares in Phase III trials in gout.[20]
Eylea (VEGF Trap Eye, Regeneron, Bayer)
Regeneron has filed a BLA with the FDA in February 2011 for VEGF Trap Eye for the treatment of neovascular form of age related macular degeneration (wet AMD). It was granted priority review the PDUFA date is 22 October, 2011. 10 to 0 The FDA advisory expert panel voted by 10 to 0 to recommend approval of this bimonthly treatment for the WMD. The VEGF Trap-Eye BLA was based on the positive results from two Phase 3 trials, the North American VIEW 1 trial and the global VIEW 2 trial. In these trials, all regimens of VEGF Trap-Eye, including VEGF Trap-Eye dosed 2 milligrams (mg) every two months (following three loading doses), successfully met the primary endpoint of non-inferiority, compared to the current standard of care, ranibizumab 0.5 mg dosed every month. The primary endpoint analysis was statistical non-inferiority in the proportion of patients who maintained (or improved) vision over 52 weeks compared to ranibizumab. A generally favorable safety profile was observed for both VEGF Trap-Eye and ranibizumab. The ocular adverse events were balanced across all treatment groups in both studies. There were no notable differences in non-ocular adverse events among the study arms. The VIEW (VEGF Trap-Eye:Investigation ofEfficacy and Safety inWet AMD) program consists of two randomized, double-masked, Phase 3 clinical trials evaluating VEGF Trap-Eye in the treatment of the neovascular form of age-related macular degeneration (wet AMD). The VIEW 1 study, which randomized 1217 patients, is being conducted inthe United StatesandCanadaby Regeneron under a Special Protocol Assessment (SPA) with theU.S. Food and Drug Administration. The VIEW 2 study, which randomized 1240 patients, is being conducted inEurope, Asia Pacific, Japan, andLatin AmericabyBayer HealthCare. The study designs are essentially identical. The primary endpoint evaluation was conducted at 52 weeks.[21][22][23][24]
Zaltrap (aflibercept, Regeneron, Sanofi Aventis) metastatic colorectal cancer (mCRC)
Zaltrap is a fusion protein angiogenesis inhibitor which binds to VEGF-A, VEGF-B and placental growth factorPositive Phase III outcome of Zaltrap as second line therapy in the Velour study in 1266 mCRC patients previously treated with oxaliplatin. Zaltrap addition to FOLFIRI increased overall survival. This is in contrast to the recent negative results from the Vital Phase III study in second line treatment for non small cell lung cancer. The drug is in Phase III trials for hormone refractory prostate cancer.[25]
The drug met its primary end point of efficacy in reducing spleen size in a European Phase III trial CONFORT II. The disease is a bone marrow disorder resulting in enlarged spleen. NDA filing planned for 2Q2011.[26]
Elvitegravir (Gilead)HIV
The 145 Phase III trial met its 48 weeks primary efficacy end point in comparative Phase III trials, which was non inferiority to raltegravir. The number of patients after 48 weeks treatment reaching viralload of < 50 counts. was 59% on elvitegrevir and 58% on raltegrevir. The ADRs were similar in both groups.There were 351 patients in each group. Patients were pretreated and had documented resistance to 2 per mlor more HIV drug classes and with viral loads of > 1000 copies ml.[27]
Laquinimod ( Teva, Active Biotech) MS[28]
Results of the Phase III ALLEGRO study as released by Teva showed that the test drug met primary and secondary efficacy end points.In the ALLEGRO study, laquinimod showed a statistically significant 23 percent reduction in annualized relapse rate, the primary endpoint, along with a significant 36 percent reduction in the risk of confirmed disability progression, as measured by Expanded Disability Status Scale (EDSS). Treatment with laquinimod was also associated with a significant reduction in brain tissue loss, as measured by a 33 percent reduction in progression of brain atrophy.
ALLEGRO was a two-year multi-national, multi-center randomized, double blind, placebo-controlled study designed to evaluate the efficacy, safety and tolerability of laquinimod in MS patients. The study was conducted at 139 sites in 24 countries and enrolled 1, 106 MS patients. Patients were randomized to receive a once-daily oral dose of 0.6 mg laquinimod or matching placebo. The primary outcome measure was the number of confirmed relapses; secondary measures included confirmed disability progression and changes in MRI active lesions.
Eighty percent of laquinimod and 77 percent of placebo patients completed the two-year study. Patients who completed the ALLEGRO study were offered to join an open-label extension phase, in which they are being treated with laquinimod 0.6 mg daily.The second laquinimod Phase III study, BRAVO, is currently ongoing with results anticipated in the third quarter of 2011. Regulatory submissions are planned in the U.S. and the EU following the availability of the BRAVO results.[28]
Levadex (dihydroergotamine DHE, MAP Pharma, Allergan) for Migraine[29][30]
LEVADEXis an orally inhaled migraine therapy in Phase 3 development. Patients administer LEVADEXthemselves using the company's proprietary TEMPO inhaler. It is a novel formulation of dihydroergotamine (DHE), a drug used intravenously in clinical settings to effectively and safely treat migraines.Results of the completed Phase III trials were published.
This was aphase 3, randomized, double-blind, placebo-controlled, parallel-group, single-attack, outpatient study of MAP0004, an inhaled dihydroergotamine conducted at 102 sites in 903 adults with a history of episodic migraine. Patients were randomized (1:1) to receive MAP0004 (0.63mg emitted dose; 1.0mg nominal dose) or placebo, administered after onset of a migraine headache with moderate to severe pain. The co-primary endpoints were patient-assessed pain relief and absence of photophobia, phonophobia, and nausea at 2 hours after treatment.
A total of 903 patients (450 active, 453 placebo) were randomized, and 792 (395 active, 397 placebo) experienced a qualifying migraine. MAP0004 was superior to placebo in all 4 co-primary endpoints: pain relief (58.7% vs 34.5%, P 2 billion/year.[38]
Bydureon vs Victoza
[39]|
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Amylin to Resubmit Diabetes Treatment to FDA
New York Times - 9 hours ago
By BLOOMBERG NEWS Amylin Pharmaceuticals, a biopharmaceutical company, said its experimental diabetes treatment Bydureon will be resubmitted for regulatory approval in the United States this quarter.
Amylin, Alkermes say diabetes drug safe for heart BusinessWeek
Amylin, Alkermes Shares Jump On Success In Bydureon Study Wall Street Journal
| Otelixizumab (GSK, Tolerx) CD3 Type 1 diabetes[40]
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Aflibercept (VEGFTrap, Regeneron, Sanofi Aventis) NSCCLC Aflibercept (VEGFTrap, Regeneron, Sanofi Aventis) failed to increase overall survival (primary efficacy end point) in the Phase III VITAL trial in difficult to treat NSCLC in comparison with Taxotere. The active drug increased PFS and ORR both secondary end points and caused more ADRs and discontinuation than the control group.The VITAL study was a multinational, randomized, double-blind trial comparing aflibercept versus placebo in combination with docetaxel patients with locally advanced or metastatic non-squamous NSCLC who have failed one platinum-based therapy. The study enrolled 913 patients who were randomized to receive intravenous (IV) docetaxel 75 mg/m2 plus either IV placebo or IV aflibercept 6 mg/kg every three weeks until disease progression, unacceptable toxicity, patient's refusal or further treatment. The primary objective of the study was to demonstrate improvement in overall survival with the combination of aflibercept and docetaxel compared with placebo and docetaxel.Previously aflibercept failed in Phase III VANILLA trial for pancreatic cancer was stopped due to lack of increase in OS. Results from other ongoing Phase III trials VENICE in 2ndline metastatic colon cancer, VELOUR in metastatic prostate cancer and AFFIRM in 1stline metastatic colon cancer are expected in the second half of 2011.It follows the Phase III failure of Nexavar (Bayer, Onyx) and Novartis/Antisoma drug ASA404. Abraxane (Celgene) increased PFS in NSCLC without reaching statistical significance and the company intends to file dossier for FDA/EMA approvals.[42] Motesanib (Amgen, Takeda) fails in NSCLC Amgen and Takeda announced top-line results from the MONET1 pivotal Phase 3 trial evaluating motesanib administered in combination with paclitaxel and carboplatin in 1, 090 patients with advanced non-squamous non-small cell lung cancer (NSCLC). The trial did not meet its primary objective of demonstrating an improvement in overall survival (OS) (hazard ratio 0.90, 95 percent CI 0.78 - 1.04, p=0.14).Motesanib is an investigational, orally-administered small molecule antagonist of vascular endothelial growth factor receptors 1, 2, and 3, platelet-derived growth factor receptors, and stem cell factor receptor.Smaller studies of motesanib inmetastatic thyroid cancerandimatinib-resistant gastrointestinal stromal tumorshad suggested the drug could be helpful. However, a phase II study inadvanced breast cancer that combined motesanib with bevacizumab(Avastin) showed no added benefit in overall response rates.[43] Xarelto (rivaroxabab, Bayer, J&J) [44] Results from the MAGELLAN Phase III clinical study evaluating rivaroxaban for the prevention of venous thromboembolism (VTE) in hospitalized patients with acute medical illness were presented at the 60th American College of Cardiology (ACC) Annual Scientific Session.In the study, rivaroxaban met its primary efficacy endpoints of demonstrating non-inferiority to enoxaparin in short-term use (2.7% in each group, 10 days) and superiority to Lovenox (enoxaparin, Sanofi Aventis) (10 days) followed by placebo in long-term use (4.4% vs 5.7%, 35 days) in the prevention of VTE in hospitalized patients with acute medical illness.[44] The principal safety outcome was the incidence of treatment-emergent major bleeding events and non-major, clinically relevant bleeding events observed no later than two days after the last intake of the double-blind study drug. The rates of primary safety events were low overall in both arms of the study, but there was a statistically significant increase in patients randomized to rivaroxaban compared with patients in the enoxaparin arm on Day 10 (2.8% vs. 1.2%, respectively; p
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