The Food and Drug Administration on Wednesday approved Brilinta, a new blood thinner from AstraZeneca that the company hopes can rival Plavix, the No. 2 best-selling drug in the world.
The agency will require a boxed warning about how the drug’s effectiveness will be reduced if it is taken with higher doses of aspirin. But the approved label — critical to marketing the drug — also says Brilinta was proved superior to Plavix in reducing heart attacks and deaths from cardiovascular causes.
“It’s good news for patients, and it’s a good result for AstraZeneca as well,” said Dr. Alex Gold, the company’s brand development leader. “We think the label has been a good outcome and will enable physicians to use the drug appropriately.”
The F.D.A. opened the United States market to Brilinta — already approved in 38 other countries — while also imposing a monitoring program to require AstraZeneca to inform physicians of the aspirin risk.
The agency’s move followed the rejection on Tuesday of another AstraZeneca drug, dapagliflozin, an experimental diabetes drug that an F.D.A. advisory panel decided in a 9-6 vote carried too high a risk of bladder and breast cancer. The F.D.A. usually but not always follows its advisory panel advice.
The blood drug Brilinta had also been under tough scrutiny by the F.D.A., analysts said, because test results in an industry-sponsored clinical trial were far worse among patients in the United States than those from the rest of the world for reasons that remain unclear.
In December, the F.D.A. rejected Brilinta in a surprising move, opposing the views of a scientific advisory panel that had voted 7-1 in favor of the drug in July 2010. The F.D.A. asked for and received more information from AstraZeneca.
In a note to investors, Timothy Anderson, analyst for Bernstein Research, said he continued to believe commercial prospects would be limited because of the pending lower prices for Plavix. The aspirin warning may be significant, he said. “It may give physicians one more reason not to use Brilinta but to stick to gold-standard Plavix.”
Brilinta also has a boxed warning about bleeding risk that also applies to other antiplatelet agents, such as Plavix. Another side effect of Brilinta, but not Plavix, is difficulty breathing in some cases. Brilinta is the latest attempt by pharmaceutical companies to outdo Plavix in the lucrative market for a pill to prevent strokes and heart attacks in coronary patients. The F.D.A. in 2009 approved a new blood thinner called Effient from Daiichi Sankyo and Eli Lilly. But it attached a black-box warning about excessive bleeding, and sales have fallen short of expectations.
Plavix was the second-best-selling drug in the world last year behind Lipitor, a cholesterol drug from Pfizer. The patent for Plavix, held by Sanofi Aventis and Bristol-Myers Squibb, expires in May 2012, and should lead to lower prices that may make Plavix more attractive as doctors and insurers weigh the costs, risks and benefits of new drugs.
In Europe, where generic forms of Plavix have been available since 2009, the low generic prices have stalled sales of the European version of Brilinta, called Brilique. It was approved by the European Union last year based on a study of 18,624 coronary patients in 43 countries.
The study, paid for by AstraZeneca, compared Brilinta and aspirin head-to-head with Plavix and aspirin. It found 16 percent fewer deaths, heart attacks and strokes in a year among Brilinta patients, with no more bleeding problems. But paradoxically, the results were opposite that among the 1,400 Americans in the trial. They had a higher rate of negative outcomes, a figure that was not statistically significant over all because of the lower number of patients, but that certainly caught regulators’ attention.
AstraZeneca has attributed the difference to higher aspirin dosing in the United States. The F.D.A. accepted that reasoning in the boxed label warning that says more than 100 milligrams a day of aspirin would “reduce the effectiveness of Brilinta and should be avoided,” but lower doses were recommended.
Brilinta prevents blood platelets from sticking together and forming clots. It is faster-acting than Plavix and reversible if the patient bleeds. Some patients respond to Brilinta who do not respond to Plavix, for genetic reasons.
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