FDA Panel Backs Broad Acute Coronary Syndromes Claim For Brilinta
Executive Summary
An FDA advisory committee's blessing of AstraZeneca's Brilinta clinical strategy should reassure other drug developers that a single pivotal trial encompassing the spectrum of acute coronary syndromes and treatment strategies can support a broad claim for reducing thrombotic events
You may also be interested in...
FDA's NME Approval Rebound At Risk: Drought Of Novel Products In Line For Action In Remainder Of 2010 Could Depress Upward Trend From First Half
Almost one-third fewer novel product applications are on FDA's user fee calendar for the second half of 2010 as compared to the docket at the same point in 2009, a dearth that could imperil the slow but steady improvement in annual new molecular entity and novel biologic approvals after the nadirs reached earlier in the decade
FDA's NME Approval Rebound At Risk: Drought Of Novel Products In Line For Action In Remainder Of 2010 Could Depress Upward Trend From First Half
Almost one-third fewer novel product applications are on FDA's user fee calendar for the second half of 2010 as compared to the docket at the same point in 2009, a dearth that could imperil the slow but steady improvement in annual new molecular entity and novel biologic approvals after the nadirs reached earlier in the decade
Brilinta Advisory Cmte. Nod Creates Postmarketing Study Quandary For FDA
With the Cardiovascular and Renal Drugs Advisory Committee's endorsement of AstraZeneca's antiplatelet agent Brilinta (ticagrelor) behind it, FDA now faces a potential challenge in devising a postmarketing study commitment aimed at addressing efficacy questions in U.S. acute coronary syndrome patients that does not also run into ethical roadblocks