AstraZeneca Fails to Gain U.S. Approval for Its Rival to Plavix - BusinessWeek

Dec. 17 (Bloomberg) -- AstraZeneca Plc failed to win U.S. approval for a new blood thinner to rival Plavix, the world’s second-best selling drug.

The Food and Drug Administration asked for additional analysis of a study called Plato comparing Brilinta with Plavix in patients with severe chest pain or earlier heart attacks, the London-based company said yesterday in a statement. The twice- daily pill won a 7-1 recommendation from an FDA advisory panel on July 28.

The FDA’s decision delays a product whose sales may have reached $2.7 billion by 2015, according to the average estimate of three analysts surveyed by Bloomberg. AstraZeneca, the U.K.’s second-biggest drugmaker, needs new products as patents expire in the next four years on the heartburn drug Nexium and the antipsychotic Seroquel, which generated a combined $9.83 billion in revenue last year.

Regulators didn’t ask for new clinical trials for the drug, known by its chemical name, ticagrelor, and “our highest priority is to provide the requested Plato analyses to the FDA,” Martin Mackay, AstraZeneca’s president of research and development, said in the company’s statement.

“The company remains confident in the submission for ticagrelor and in its ability to respond to the agency’s questions,” AstraZeneca said in its statement.

via businessweek.com

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