UPDATED: AstraZeneca wins FDA approval for blockbuster hopeful Brilinta

The FDA has approved AstraZeneca's ($AZN) blood thinner Brilinta (ticagrelor) for acute coronary syndromes, breaking the Big Pharma company's long losing streak at the agency and pushing the regulator's approval record on new drugs so far this year to 21--a match for all of last year. But the approval did come with a catch: AstraZeneca will have to conduct a risk evaluation and mitigation strategy program, including outreach to make sure doctors tell patients the risk of bleeding rises when they take aspirin at doses above 100 milligrams a day.

"In clinical trials, Brilinta was more effective than Plavix in preventing heart attacks and death, but that advantage was seen with aspirin maintenance doses of 75 to 100 milligrams once daily," said Norman Stockbridge, director of the division of cardiovascular and renal products in the FDA's Center for Drug Evaluation and Research.

The analysts who have been following AstraZeneca's long quest to gain approval for the drug often split on how the FDA would come down. And AstraZeneca, which has experienced a series of bitter setbacks in the clinic, always knew it had a lot riding on the decision. As the Financial Times noted, the consensus among analysts is that Brilinta should garner $2 billion in annual sales by 2015. But analysts at both Jefferies and Sanford C. Bernstein commented earlier today that even with an approval, there are some significant doubts about the kind of commercial success Brilinta can expect.

"We continue to believe that the product will disappoint commercially," noted Sanford C. Bernstein, putting its forecast for 2015 at a relatively modest $750 million. Jefferies lowered its peak sales estimate to $1 billion. Bernstein's Tim Anderson wrote: "We think the biggest impediment to Brilinta's uptake will be the availability of generic Plavix, which will be available at a fraction of the price of Brilinta."  

AstraZeneca's win at the FDA comes on the heels of a 9 to 6 FDA panel vote against dapagliflozin, a pioneering diabetes drug designed to lower blood sugar by excreting it in urine. AstraZeneca and Bristol-Myers Squibb are partnered on that deal and they plan to push ahead in the unlikely hope that the FDA could overrule the experts and grant approval.  

- see the FDA release
- read the Financial Times story
- here's the Bloomberg report

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