AZ's blockbuster Brilinta wins landslide FDA panel vote

Tools

AstraZeneca scored a big win in front of an FDA advisory panel on Wednesday afternoon, gaining solid support for its blockbuster blood thinner Brilinta in a seven-to-one vote in favor of approval.

AstraZeneca's biggest obstacle was the relatively small contingent of 1,413 American patients in a large international Phase III who failed to benefit from the drug. But the 17,000 patients who participated in the study in 42 other countries demonstrated a sharp drop in deaths and heart attacks, leading the panelists to conclude that the anti-clotting therapy should be effective in a broad patient population.

"The overall results are so striking," said the University of Minnesota's James Neaton, who supported the application. Neaton, though, also reflected some general anxiety about the lack of U.S.-related efficacy data, which AstraZeneca has attempted to blame on a regular use of aspirin among the patients recruited in this country. "We are confident in the [effectiveness] of ticagrelor when used with low-dose aspirin," said AstraZeneca's Jonathan Fox, according to a report by Dow Jones.

The vote puts AstraZeneca on the path to full FDA approval--something that is likely given the lopsided vote in Brilinta's favor. If it does win full approval later this year, analysts project that the drug will quickly rack up more than a billion dollars in sales during its first year and has the potential to hit mega-blockbuster status with $4 billion in peak annual sales. With its patent on Nexium set to expire soon, a big regulatory win here is just what the pharma company needs most.

- here's the story from Reuters
- here's the report from Dow Jones

Related Articles:
AZ's Brilinta garners favorable reviews from FDA staffers
AstraZeneca files Brilinta NDA
AZ wows analysts with new Brilinta data
Brilinta bests Plavix in trial

Filed Under