AstraZeneca Plc has secured U.S. approval for its heart drug Brilinta that will rival the world’s second-best selling drug Plavix, Bloomberg reported.
The Food and Drug Administration has approved Brilinta for use by patients with severe chest pain or heart attack history to cut the risk of heart attacks, strokes and death.
U.K.-based second-biggest drug maker needs new products as patents expire in the next four years on the heartburn drug Nexium and the antipsychotic Seroquel which generated a combined $10.3 billion in revenue last year.
According to the average estimate of seven analysts surveyed by Bloomberg, the sales of heart drug Brilinta may reach $1.14 billion by 2014.
Norman Stockbridge, director of the FDA’s Division of Cardiovascular and Renal Products said, “In clinical trials, Brilinta was more effective than Plavix in preventing attacks and death, but that advantage was seen with aspirin maintenance doses of 75 to 100 milligrams once daily.
Brilinta won the approval from the European Union in December under the name Brilique.
”AstraZeneca may “strengthen the image of the brand” by voluntarily conducting studies to clarify Brilinta’s effectiveness in U.S. patients, even though the FDA didn’t call for postmarketing trials,” said Tim Anderson, an analyst with Sanford C. Bernstein & Co in New York.
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AstraZeneca Plc wins US approval for heart drug Brilinta
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Food and Drug Administration, heart drug, heartburn drug, Sanford C. Bernstein, Tim Anderson, U.K.-based second-biggest drug maker
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