An FDA advisory panel voted today 7-1 to recommend that AZ's potential blockbuster blood thinner, Brilinta, be approved by the agency in September.
Brilinta will become a direct competitor for Sanofi-Aventis' and BMS' Plavix - the world's second leading selling drug at more than $9 B annually. Brilinta, if approved in September, is expected to easily top $1 B by 2014.
Panel members issued their approval even as they struggled to explain why the 1400+ patients, out of the more than 18,000 patients tested worldwide, did not respond markedly different than US patients on aspirin. Higher average aspirin doses in the US were posited as one possible explanation but certainly this was not conclusive.
On balance, the panel recommended approval based on the sterling results seen in the rest of the world when comparing Brilinta to Plavix where heart attack, stroke or cardiovascular-related death dropped to a rate of 9.8 percent as compared to 11.7 percent after one year.
We await the news of the FDA in September.
Posted by Bruce Lehr July 28th 2010.