Astrazenecas Brilinta Safely Cuts Heart Risks, Fatality In Study
Brilintas potency didnt cause more episodes of serious bleeding, a common complication seen with drugs that ward off heart conditions by preventing blood clots from developing, the research showed. The findings position Brilinta to rival Plavix, the second-biggest selling medicine in the world with almost $10 billion in annual revenue, for millions of patients suffering from heart attacks or severe chest pain.
About 1.3 million Americans are hospitalized each year with heart attacks and chest pain known as acute coronary syndromes. While aspirin and Plavix have lowered their subsequent health risks, cardiovascular disease remains the leading cause of death worldwide. Death from any cause was also significantly lower in patients taking Brilinta, according to the results of the study known as Plato.
“I think this will become the new standard of care,” said Douglas Weaver, a cardiologist at Henry Ford Hospital in Detroit and a past president of the American College of Cardiology, in an interview. “Its more rapid, more effective and it appears to be safer” than Plavix and another competitor, Effient, from Eli Lilly & Co. and Daiichi Sankyo Co. “I dont think they could have done much better than they did in this trial.”
The trial, funded by London-based AstraZeneca, included 18,624 patients and was one of the most eagerly anticipated findings presented at the European Society of Cardiology meeting in Barcelona this week. It was simultaneously published in the New England Journal of Medicine.
Sales Estimate
Sachin Jain, an analyst at Bank of America Merrill Lynch in London, forecast $500 million in sales by 2015 in an Aug. 17 note to investors, and said he may raise his estimate to $1.3 billion if the drug has a meaningful benefit without serious side effects.
AstraZeneca needs Brilinta to help replace sales lost to generic competition for its best-selling drugs, as products including Seroquel that now account for about 62 percent of the companys revenue will face lower-priced competition by 2014. The Brilinta findings may not be enough to replace the lost sales, wrote Kevin Wilson, an analyst at Citigroup Inc. in London, in an Aug. 19 note to investors.
“Brilinta peak upside sales of $4 billion would be expected to be reached more than five years post-launch, once physicians become comfortable with how to get the best out of the product,” he wrote. “Even exceptional Brilinta success is not enough,” given the time it would take for doctors to embrace it, he said.
Seeking Approval
AstraZeneca plans to file for approval of Brilinta in the fourth quarter and hopes to begin selling it next year, said Gunnar Olsson, the companys head of cardiovascular therapy.
Brilinta, Plavix and Effient all work by preventing platelets from clumping together in the blood to form clots. Plavix and Effient, which was approved this year in Europe and the U.S., last for the life of the platelet, or about a week, and are given once a day. Brilinta needs to be taken twice daily. About 30 percent of patients dont respond well to Plavix. Brilintas effects wear off in a few days, making surgery easier for patients who need it.
Huge Conundrum
“Its a huge conundrum, a headache for doctors, hospitals and patients,” he said in a telephone interview. “This opens the door. Its a neat differentiating factor that could open up treatment options.”
In the study, 9.8 percent of patients taking Brilinta for a year after being treated for a heart attack or worsening chest pain suffered another heart attack or stroke, or died from vascular disease, compared with 11.7 percent of those given Plavix. Overall, 4.5 percent of Brilinta patients died from any cause, significantly fewer than the 5.9 percent of Plavix patients who died.
The rates of major bleeding were similar between the two groups, occurring in 11.6 percent of those on Brilinta and 11.2 percent of those on Plavix. Fatal bleeding in the brain was more frequent in those given Brilinta, while fatal bleeding in other areas was more common with Plavix. Brilinta was linked to more serious bleeding in the brain and stomach of patients who didnt undergo bypass surgery, the study found.
Safety Monitoring
In an accompanying comment in the New England Journal, Albert Schoemig of the German Heart Centre in Munich wrote that the safety of Brilinta, also known as ticagrelor, needs to be tracked closely.
“The whole story concerning the adverse effects of ticagrelor may require evaluation in a much larger number of patients, something that may be beyond the capacity of a randomized trial,” Schoemig wrote. “We should carefully monitor patients receiving this drug to establish the overall impact of its side effects.”