US FDA extends approval time for AstraZeneca's Brilinta; OKs Savient's Krystexxa, which could lead to sale of the firm

The US Food and Drug Administration has extended the time to complete its review of the New Drug Application for Anglo-Swedish drug major AstraZeneca’s (LSE: AZN) Brilinta (ticagrelor), the company announced. Earlier this year, an FDA advisory panel voted seven to one to recommend approval of the drug (The Pharma Letter July 29).

According to the drugmaker, the FDA has extended the Prescription Drug User Fee Act (PDUFA) date from September 16 to December 16, 2010, and AstraZeneca says it will continue to work closely with the FDA to support the review of the ticagrelor NDA.

Ticagrelor (which has also been registered under the name Brilique), is an investigational oral antiplatelet treatment for acute coronary syndromes (ACS), or blocked arteries. Ticagrelor is a direct-acting P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). Ticagrelor is the first reversibly-binding oral ADP receptor antagonist. The drug is currently under regulatory review in nine additional territories around the world, including the European Union, Canada, and Brazil, AstraZeneca noted.