July 21 (Bloomberg) -- AstraZeneca Plc won U.S. approval of its heart drug Brilinta, a potential $1 billion seller that will rival Plavix, the world’s second-best selling drug.
The Food and Drug Administration cleared Brilinta for use by patients with severe chest pain or heart attack history to cut the risk of heart attacks, strokes and death, the agency said yesterday in a statement. Brilinta’s label must include a boxed warning, the agency’s strictest caution, about a risk of bleeding and a reduction in the drug’s effectiveness if taken with more than 100 milligrams of aspirin a day.
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 $10.3 billion in revenue last year. Brilinta sales may reach $1.14 billion by 2014, according to the average estimate of seven analysts surveyed by Bloomberg.
“In clinical trials, Brilinta was more effective than Plavix in preventing heart attacks and death, but that advantage was seen with aspirin maintenance doses of 75 to 100 milligrams once daily,” Norman Stockbridge, director of the FDA’s Division of Cardiovascular and Renal Products, said in the statement.
The FDA delayed a decision in December, asking for more analysis of the London-based AstraZeneca’s Plato study comparing Brilinta, also known as ticagrelor, with Plavix, made by New York-based Bristol-Myers Squibb Co. and Paris-based Sanofi.
Approved in Europe
Brilinta won approval from the European Union in December under the name Brilique.
AstraZeneca gained 14 pence, or less than 1 percent, to 3,032.5 pence yesterday in London trading. The drugmaker has returned 3.8 percent this year, compared with 6.7 percent for the 17-stock Bloomberg Europe Pharmaceuticals Index.
Acute coronary syndrome affects more than 1 million people in the U.S. each year, David Brennan, AstraZeneca’s chief executive officer, said in yesterday’s statement.
“The fact that physicians have a new and more effective treatment option” than Plavix “to help reduce the rate of heart attack and cardiovascular death in these patients is an important advance,” Brennan said.
The twice-daily Brilinta pill won a 7-1 recommendation from an FDA advisory panel on July 28, 2010, as committee members expressed concern that study participants in the U.S. and Canada fared worse on Brilinta than people in other parts of the world. The agency’s advisers said the findings may be the result of chance and could be examined in a new trial after approval.
While FDA staff last July rejected AstraZeneca’s suggestion that higher U.S. aspirin use contributed to the outcome, the agency said yesterday that aspirin can reduce Brilinta’s efficacy.
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.
“Without putting this issue to rest, and with the label warning as it currently reads, we believe payers in the U.S. will have ammunition to disadvantage Brilinta, especially knowing that U.S. generic Plavix will launch in May 2012,” Anderson said yesterday in a note to investors.
The agency is requiring AstraZeneca to conduct an “educational outreach” to notify physicians of Brilinta’s reduced efficacy in patients who take more than 100 milligrams of aspirin a day. That may give doctors “one more reason to stick to the gold-standard Plavix,” Anderson said.
“The current treatment paradigm in the U.S. is to use high-dose aspirin more often than low-dose aspirin,” he said. “What AstraZeneca will effectively be trying to do is change this entrenched behavior, and this could be difficult.”
Bristol-Myers had sales of $6.67 billion from Plavix in 2010, while partner Sanofi had 2.08 billion euros ($2.94 billion) from the drug. Brilinta will also compete with Effient, from Indianapolis-based Eli Lilly & Co., approved in July 2009 with a warning on bleeding risk. Lilly reported global sales of $115 million last year with partner Daiichi Sankyo Co. of Tokyo.
All three drugs are pills designed to prevent platelets in the blood from clumping together to form clots, which can cause heart attacks and strokes.
Plavix and Effient are taken daily and remain effective for one week after treatment is halted. Brilinta wears off more quickly, so it may pose a lower risk of bleeding for surgery patients.
In AstraZeneca’s key study of 18,624 people, 9.8 percent of patients on Brilinta for a year had a heart attack, stroke or died from cardiovascular disease, compared with 11.7 percent of those on Plavix. A related study also showed AstraZeneca’s drug was effective regardless of the patients’ genetic makeup, unlike Plavix, which doesn’t work in patients with a certain genetic variation.
Lipitor, a cholesterol pill made by New York-based Pfizer Inc., is the world’s best-selling drug with 2010 revenue of $10.73 billion.