June 10, 2010 (Gaithersburg, Maryland) — So much for the dog days of summer: three of the most closely watched drugs in recent memory are now scheduled to go before their respective FDA advisory panels in the next few months.
First up is the much-anticipated two-day rosiglitazone (Avandia, GlaxoSmithKline) discussion. As previously predicted by heartwire , the rosiglitazone panel meeting will take place July 13–14 and will be a joint meeting of the Endocrinologic and Metabolic Drugs and the Drug Safety and Risk Management advisory committees. According to the FDA's calendar posting, the committees will review results from the Rosiglitazone Evaluated for Cardiac Outcome and Regulation of Glycemia in Diabetes (RECORD) trial, as well as observational data, health-claims data, and a meta-analysis of controlled clinical trials. The FDA also plans to present its meta-analysis of several trials of pioglitazone (Actos, Takeda Pharmaceuticals) to help panel members understand the relative risk and benefits of the two market-approved thiazolidinediones.
Rosiglitazone was first approved by the FDA in 1999, but concerns over its risk/benefit profile have led to mounting calls to stop the ongoing comparator trial addressing cardiovascular safety, TIDE, and to pull the drug from the US market.
Two weeks later, ticagrelor (Brilanta, AstraZeneca) makes its debut before the Cardiovascular and Renal Drugs Advisory Committee, July 28. As previously reported by heartwire , ticagrelor first set chins wagging at the European Society of Cardiology (ESC) 2009 meeting with the presentation of the phase 3 PLATO results, showing that the new, twice-daily, oral antiplatelet agent reduced the rate of MI/stroke/CV death in ACS patients, as compared with clopidogrel. PLATO data resurfaced in late-breaking clinical-trial sessions for at least two additional meetings, where additional subset analyses were presented. AstraZeneca submitted its new drug application for ticagrelor to the FDA last November.
Next up is dabigatran (Pradax, Boehringer Ingelheim). While the drug is not formally scheduled in the confirmed FDA advisory committee calendar, heartwire has learned that dabigatran will be the focus of the September meeting of the Cardiovascular and Renal Drugs Advisory Committee. A date of September 17 is listed in the tentative calendar but may still change. The FDA publishes a Federal Register notice 15 days in advance of each upcoming advisory committee meeting to formally announce the drug being discussed and will not currently confirm or deny the topic of the September meeting.
As reported by heartwire , dabigatran jostled for the limelight with ticagrelor at ESC 2009, where the RE-LY results were first presented showing that the new oral anticoagulant dosed at 150 mg twice a day reduced the annualized risk of the primary end point--stroke, peripheral embolic events, and the risk of hemorrhagic stroke--compared with warfarin, without increasing the risk of bleeding. Subsequent analyses were presented at the 2010 International Stroke Congress and AHA 2009 meetings. The drug is already approved for venous thromboembolism (VTE) prevention during hip- and knee-replacement surgery in the European Union and Canada.
Dabigatran is one of several new anticoagulants in late-stage testing, hoping to become the number-one warfarin competitor and obviate the need for cumbersome INR testing.
Each FDA meeting will be covered in depth by heartwire ; receive up-to-the-minute updates on how the meetings are progressing by following theheart.org on twitter.
No comments:
Post a Comment