Thursday, 21 July 2011

FDA approves AstraZeneca's Brilinta

AstraZeneca (LSE: AZN, OMXS: AZN, NYSE: AZN) has more than made up for yesterday’s decline when it announced after market close yesterday that FDA has approved blood thinner Brilinta (ticagrelor) to reduce the risk of heart attack and cardiovascular death in adult patients with acute coronary syndrome. The drug’s label will include a black-box warning about risk of significant, sometimes potentially fatal, bleeding and reduced efficacy if taken with more than 100 milligrams of aspirin a day.

FDA asked for more information in comparison to Plavix last December delaying approval. Brilinta was approved in Europe in the same month under the name Brilique. The drug is a potential blockbuster and removes some of the uncertainty as AstraZeneca has some big selling drugs coming out of patent protection in relatively near future.

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