U.S. FDA Staff Backs Lilly, Daiichi Anti-Clot Drug

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U.S. regulatory staff recommended approval of Eli Lilly and Co's and Daiichi Sankyo Co Ltd's anti-clotting drug prasugrel on Friday, but the endorsement did not soothe anxious investors who said concerns over cancer and bleeding may limit use.

Eli Lilly shares fell more than two percent as investors worried lingering safety issues could limit its ability take away market share from its top rival, Bristol-Myers Squibb Co and Sanofi-Aventis SA's blockbuster Plavix.
"It looks like the FDA is recommending for approval but with massive restrictions. It would be the most restrictive label I've ever seen, if they actually approve this thing," Natixis Bleichroeder analyst Jon LeCroy told Reuters.
FDA's released its analysis ahead of an advisory panel meeting on Tuesday to discuss whether to approve the drug. FDA officials will weigh their vote in making the final decision.
The companies have been waiting for more than a year for the FDA to rule. The agency has twice delayed its verdict on the drug, which would compete directly against Plavix, the world's second-largest selling medicine.
Prasugrel, which the companies plan to sell under the brand name Effient, should be approved to reduce heart attacks in patients managed through angioplasty, the staff said.
Clinical trial data "demonstrated prasugrel's superiority, not to a placebo, but to an active drug ... prasugrel's efficacy seems beyond question," they said, adding its benefits outweighed its risk of excess bleeding.
But they also recommended against its use in older patients and others with a higher risk of bleeding. Patients should also be told about the bleeding concerns and given appropriate advice, the staff said.
Most notably, FDA reviewers expressed concern about prasugrel's association with cancer in the trial, which showed 27 cases of cancer in prasugrel patients compared with 19 in Plavix. While the FDA said that could be due to chance, it said the companies would need to gather more data after approval.
Some staffers said the cancer risk should be highlighted on the drug's label and FDA said it would ask its advisers whether prasugrel should carry the strongest warning possible, a so- called Black Box that severely restricts advertising.
Such warnings could dent what company officials have said may be a multibillion dollar seller. Rival Plavix took in $4.92 billion in U.S. 2008 sales, according to Bristol-Myers, while Sanofi said it would announce sales figures Feb. 11.
Prasugrel "will have a number of label disadvantages relative to Plavix that likely (will) result in relatively narrow use of the product, despite impressive efficacy," JP Morgan analysts said.
BMO Capital Markets analyst Bert Hazlett stuck to his peak sales forecast of at least $1 billion a year, but said a black box would likely prevent sales from rising much higher.
Deutsche Bank analyst Barbara Ryan estimated sales at $50 million in 2009, with steady growth to $1.3 billion in 2013.
Both prasugrel and Plavix aim to prevent dangerous blood clots that can cause heart attacks, strokes and other serious complications by preventing blood cells called platelets from sticking together.
Clinical trial data showed prasugrel was 19 percent more effective than Plavix in preventing strokes, heart attacks and heart-related deaths, but caused more serious bleeding.
At Tuesday's meeting, the FDA said it will ask whether the data are strong enough to allow prasugrel to be marketed as a superior treatment.
Eli Lilly shares were off less than one percent at $37.72 after earlier rising 2.7 percent in premarket trading. Bristol- Myers and Sanofi shares were also off less than 1 percent at $21.70 and $28.39, repectively, on the New York Stock Exchange.
Separately, Eli Lilly said the data showed prasugrel was an important advancement for anti-clotting treatment, noting European regulators recommended its approval in December. It also suggested a lower dose for older patients.
"There is a clear medical need for improved therapies in the treatment of patients" with signs and symptoms of heart attack, it wrote in documents also released on Friday.