Brilinta face three month setback at FDA

The US Food and Drug Administration (FDA) has extended the time to finish reviewing AstraZeneca’s NDA for BRILINTA (ticagrelor) from originally scheduled 16 September 2010 to 16 December 2010. The company said the FDA needed more time to study the application

From the pipeline of the anglo-Swedish drugmaker, Brilinta is seen as the next blockbuster for the company. The platelet aggregation inhibitor Brilinta has win the solid support from FDA advisory panel in July. The Cardiovascular and Renal Drugs Advisory Committee recommended the Brilinta to reduce the risk of major adverse cardiac events in patients with acute coronary syndromes.

Brilint is also under review in nine other territories, including the European Union, Canada and Brazil.

The FDA panel voted 7-1 in favour to recommend approval of Brilinta for patients suffering from heart attacks or chest pains, based on the 18,624-patient PLATO clinical study, which found that Brilinta had better mortality rates than clopidogrel (9.8% vs. 11.7%, p<0.001) in treating patients with acute coronary syndrome. However there was a difference in effectiveness between US and non-US participants in the trial.

It is not clear if the difference in effectiveness is the reason for the delay. “we remain confident in the application and will continue to work closely with the FDA to support the review,” said AstraZeneca spokeswoman Abigail Baron.