US FDA advisory panel backs AstraZeneca's Brilinta, as firm posts 22% rise in core EPS for 2nd-qtr 2010

The US Food and Drug Administration Cardiovascular and Renal Drugs Advisory Committee has recommended the approval of Anglo-Swedish drug major AstraZeneca's investigational drug ticagrelor - provisional trade name Brilinta - for the reduction of thrombotic events in patients with acute coronary syndromes (ACS, or blocked arteries), the company revealed last night.

Members of the advisory panel voted seven to one to recommend approval of Brilinta for certain heart patients who need artery-clearing procedures, as well as in those being medically managed and not expected to undergo surgical treatment.

AstraZeneca shares, which had risen 3.2% near the end of regular trading on the New York Stock Exchange, gained another 1% after hours to $52, following the panel vote. Analysts have forecast that Brilinta could generate annual revenues of $1.7 billion globally by 2014, although the Nomura team said it is less optimistic, anticipating sales of just $724 million (The Pharma Letter July 19).