Brilinta – AstraZeneca’s new blood thinner faces FDA hurdle

By Dr. Ananya Mandal, MDDec 20 2010

AstraZeneca’s new blood thinner that was pitched against Plavix, the world’s second-best selling drug failed to live up to expectations making stocks drop to a two year low, the steepest decline since Nov. 21, 2008, and the worst performance today on the 18-company Bloomberg Europe Pharmaceutical Index.

The Food and Drug Administration requested for a more detailed analysis of the new drug Brilinta’s study against Plavix. The phase III study was called Platelet Inhibition and Patient Outcomes (PLATO). The drugs were marketed in patients with severe chest pain or earlier heart attacks. The twice-daily pill won a 7-1 recommendation from an FDA advisory panel on July 28 although all committee members had expressed concern about study results in the U.S., where many patients were also receiving high-dose aspirin.

Eric Le Berrigaud, an analyst at Raymond James in Paris said, “This is bad news for AstraZeneca… Brilinta is the biggest growth driver in AstraZeneca’s pipeline and it’s taking a hit.” Martin Mackay, AstraZeneca’s president of research and development explained that the FDA have not asked for new clinical trials for the drug Brilinta or ticagrelor, and “our highest priority is to provide the requested Plato analyses to the FDA,” he added. The AZ statement read, “The company remains confident in the submission for ticagrelor and in its ability to respond to the agency’s questions.”

Brilinta’s market competitors are Plavix from New York-based Bristol-Myers Squibb Co. and Paris-based Sanofi-Aventis SA, and Effient, sold by Eli Lilly & Co. For Plato 18,624 people were included. 9.8 percent of patients on Brilinta for a year had a heart attack, stroke or died from cardiovascular disease, compared with 11.7 percent of those on Plavix. Another study showed that where Plavix may be rendered ineffective in some people with a different genetic makeup, Brilinta works in all patients with equal efficacy.

FDA approval for Brilinta has been delayed once, in September. This comes as an additional delay. Brilinta was approved this month in Europe, where it is known as Brilique. AstraZeneca will likely begin marketing the drug in the second half of 2011 once prices are negotiated with member countries revealed company spokeswoman Sarah Lindgreen.