Handing a big victory to Eli Lilly and Daiichi Sankyo, the FDA announced on Friday that it approved the blood thinner prasugrel, which is widely considered a likely blockbuster that can go head-to-head with Plavix. One Japanese analyst pegged peak annual revenue at $1.6 billion.
The therapy, which will be marketed as Effient, was OK'd to help reduce the risk of blood clots in patients undergoing angioplasty. But analysts raised concerns that its market potential is likely to be reined in by regulators' demands for a black box warning to flag concerns about potentially fatal bleeding.
"Effient offers physicians an alternative treatment for preventing dangerous blood clots from forming and causing a heart attack or stroke during or after an angioplasty procedure," said John Jenkins, director of the FDA's Office of New Drugs. "Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug."
The approval comes after a long quest. Lilly and Daiichi originally filed for an approval more than a year and a half ago, but the agency repeatedly delayed a final decision. An advisory board recommended approval back in February. The approval is particularly important for Daiichi, which has had to deal with declining revenue triggered by government-mandated price cuts.
- see the FDA approval announcement
- read the story from the Wall Street Journal