Citi positive on AstraZeneca's heart drug approval

20th Jul 2011 13:29

Citi said AstraZeneca's blockbuster heart drug brilinta has a 60% to 70% chance of approval by the U.S. Food and Drug Administration but is contingent on post-marketing studies with a sufficient number of US patients to confirm the benefit with low-dose of aspirin.Citi analyst Mark Dainty expects AstraZeneca's "shares to move in the order of 5% up or down depending on the outcome." The FDA is expected to announce its results today (PDUFA date) in the afternoon or after market close.Brilinta, designed to use with aspirin for the treatment of patients with acute coronary syndromes or various heart-related problems, has already been approved in Europe and has a potential to rake in billions of dollars in revenue for AstraZeneca. The blood thinner, if approved, will compete with French drugmaker Sanofi Aventis and Bristol Myer Squibb's Plavix - the world's second biggest selling drug.In addition to the heart drug, Dainty also said he expects the FDA to follow the advice of the advisory committee on the company's diabetes drug. The committee had recommended rejecting dapagliflozin, for the treatment of type 2 diabetes, over concerns of cancer and liver issues.However, he added, "Cancer and liver issues outweighed potential cardiovascular (CV) benefit and weight reduction."Dainty expects the FDA to issue a complete response letter - a letter conveying that the FDA cannot approve the drug in the present form - and request for further safety studies before approval.He added, "Although there remains a chance that the European authorities take a more positive view in 4Q11, this now seems unlikely."Shares of AstraZeneca slipped 1.7% to 2,966p in London. AR