UPDATE 3-US FDA advisers to review Lilly, Daiichi clot drug
(Adds analyst comment, shares, byline)
By Lewis Krauskopf
NEW YORK, Dec 31 (Reuters) - A U.S. Food and Drug Administration advisory panel will review Eli Lilly's (LLY.N) and Daiichi Sankyo's (4568.T) blood-clot preventer prasugrel, the drugmakers said on Wednesday, adding a new hurdle for approval of the potential blockbuster medicine.
The FDA's cardiovascular and renal drugs committee will review prasugrel on Feb. 3, the companies said, confirming speculation that such a public hearing was inevitable after the FDA twice delayed a decision on the drug.
"This announcement should be viewed positively as it establishes a visible regulatory timeline and possibly resolves FDA uncertainty," Cowen and Co analyst Steve Scala said in a research note.
Shares of Indianapolis-based Lilly rose 0.3 percent, in line with the drugs group.
Lilly and Daiichi said they will have further discussions with the FDA in preparation for the committee meeting on prasugrel, which would compete directly with Plavix, one of the world's largest-selling medicines. Plavix is sold by Bristol-Myers Squibb (BMY.N) and Sanofi Aventis (SASY.PA).
The FDA generally follows the advice of its advisory panels, although there are a few recent examples of the agency going against committee recommendations.
"We welcome the opportunity to discuss any and all of the prasugrel data with the advisory committee and the agency, just as we have throughout the ongoing review," said John Alexander, Daiichi's global head of research and development, in a statement.
The FDA in September let an action date for an approval decision pass, saying it had not completed its review but gave no indication of when it might act. That came after a prior three-month review extension.
Despite those delays, Daiichi's head of U.S. commercial operations told Reuters in November he was confident the drug -- which would be marketed as Effient -- would soon win U.S. approval.
The medicine has so far fared better in Europe, where a panel of experts recommended its approval earlier this month.
Prasugrel is widely considered the most important in Lilly's developmental pipeline.
Like Plavix, prasugrel works by stopping blood cells called platelets from clumping together. It would be used to prevent problematic blood clots in patients who have undergone artery-clearing procedures.
The drug's main study contained mixed results -- potent effectiveness at preventing heart problems, but with heightened bleeding risks.
Lilly shares were up 12 cents at $39.79 in morning trading on the New York Stock Exchange. (Reporting by Lewis Krauskopf; Editing by Dave Zimmerman and Brian Moss)
