Finalmente approvato l'Effient!!
US FDA approves Lilly, Daiichi's blood thinner
WASHINGTON (Reuters) - U.S. health officials approved Eli Lilly and Co and Daiichi Sankyo Co Ltd's blood thinner Effient after several delays, and called for the pill to carry a strong warning about bleeding risks.
The drug, a rival to Sanofi-Aventis SA and Bristol-Myers Squibb Co's blockbuster drug Plavix, will include a "black box" warning about its potential for "significant, sometimes fatal, bleeding," the Food and Drug Administration said on Friday.
Both drugs aim to prevent dangerous blood clots that can cause heart attacks or strokes. Studies showed Effient was more effective at preventing heart problems than Plavix, but had a higher risk of bleeding.
"This is a drug that does some very good things - it's a very important part of the therapeutic landscape - and it has some things you've got to watch for," Dr. Robert Temple, head of the FDA office that reviews heart drugs, told reporters.
The approval of Effient, also known as prasugrel, comes after an 18-month review in which FDA officials twice postponed their decision.
Controversy flared last year when the FDA removed a cardiologist critical of the drug from one of its independent advisory panels after Lilly contacted the agency. The action sparked a congressional investigation.
Investors have been anxiously awaiting a verdict on the drug that some see reaching nearly $1 billion in sales by 2013 and $2 billion a decade from now.
Eli Lilly and Daiichi said they would launch the drug "in the coming weeks." While the companies noted the higher bleeding rate, they added in a statement that using the drug with appropriate patients "may help reduce this risk."
The approval initially sent Lilly shares more than 2 percent higher, but the stock gave up some ground to close up 1 percent at $33.32 on the New York Stock Exchange.
SLOW UPTAKE
"The black box is slightly disappointing. It means there will probably be slower uptake in the marketplace," said Natixis Bleichroeder analyst Jon LeCroy.
The drug's label also says Effient should not be used by patients with existing bleeding problems, a history of stroke or an urgent need for surgery. Cancer cases also are mentioned lower on the label, with the FDA requiring further study.
An earlier clinical trial found newly diagnosed cancers were reported in 1.6 percent of Effient patients compared with 1.2 percent of others who got Plavix. Effient's label says "it is unclear if these observations are causally-related or are random occurrences."
Even with the drug's risks, cardiologists were "pretty excited," said LeCroy, noting Effient's ability to work more quickly than Plavix, an $8-billion-a-year drug.
One potential hurdle is price, with Plavix facing generic competition in 2011 that will pit cheaper versions of that drug against Effient.
David Moskowitz, an analyst at Caris & Company, said Lilly's drug will likely only take up to 25 percent of the market at its peak, estimating $500 million in sales by 2013.
"It's going to take time for them to penetrate the market with this label," he said.
Javan Collins, Lilly's cardiovascular business unit leader, said the company would "be very competitive" and would deploy its sales force to doctors within a month. The drug's price will be finalized next week, he added.
James Floyd, a researcher at Public Citizen's Health Research Group, said that once Effient was used more widely, the number of patients with dangerous bleeding was likely to spike given that company studies excluded certain kinds of people.
"You're going to see a lot more bleeding in general practice," said Floyd, whose advocacy group had urged the FDA to halt its review of the drug.
Effient's instructions do not limit it to short-term use but if patients use it "for a long time, you have to think about the fact that bleeding episodes continue and that the size of the benefit is somewhat smaller," FDA's Temple said.
Asked about the FDA's delayed review, Temple said FDA staff "spent a lot of time making sure we understood everything ... and had labeling that made it clear," he said. (Additional reporting by Deena Beasley in Los Angeles, editing by Andre Grenon and Tim Dobbyn)
, secondo me non è una buona notizia per LLY, vedremo come la prenderà il mercato..
