AstraZeneca Replies to FDA’s Decision on Brilinta
AstraZeneca Plc told the U.S. Food and Drug Administration that high-dose aspirin most likely caused different results in a test of the Brilinta blood thinner, citing an analysis requested by the regulator.
The FDA will now decide whether AstraZeneca’s response on the drug, also known as ticagrelor, is complete and whether to start a two-month or six-month review, the London-based company said in a statement today. The company is seeking approval to sell Brilinta as a treatment to prevent artery-blocking clots that can cause heart attacks and severe chest pain.
The FDA last month asked for additional analysis of a study called Plato comparing Brilinta with the Plavix blood thinner. The twice-daily pill won a 7-1 recommendation from an FDA advisory panel on July 28. All committee members had expressed concern that study participants in the U.S. and Canada did worse on Brilinta than people in other parts of the world. Many North American patients were also receiving high-dose aspirin, AstraZeneca said.
“AstraZeneca remains of the view that either the play of chance or an interaction between high-dose aspirin and ticagrelor are viable explanations for the efficacy differences observed in a subset of U.S. patients in the Plato trial,” the drugmaker said today.
The shares gained 41 pence, or 1.4 percent, to 2,963.5 pence in London trading.
Aspirin Theory
FDA staff in July rejected AstraZeneca’s suggestion that higher U.S. aspirin use contributed to the outcome. The agency noted that rates of bleeding, a potentially serious side effect, were higher immediately after patients received Brilinta, before there would have been a chance for interaction with aspirin, than they were with Plavix, said Jeffrey Holford, an analyst at Jefferies International Ltd. in London.
The company’s statement “does not sound as if the re- analyses provide absolute clarity on the issue,” Holford, who rates the shares a “hold,” wrote in a note to clients today. “The FDA may feel that it needs to request an additional trial.”
The FDA’s decision delayed a product whose sales may have reached $2.5 billion by 2016, according to the average estimate of three analysts surveyed by Bloomberg. It aims to take on the world’s second-best selling drug Plavix, from New York-based Bristol-Myers Squibb Co. and Paris-based Sanofi-Aventis SA.
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.
To contact the reporter on this story: Allison Connolly in Frankfurt at aconnolly4@bloomberg.net.
To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net
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