WASHINGTON (Reuters) - U.S. regulators have granted priority review to a closely watched drug for preventing blood clots being developed by Eli Lilly and Co and Daiichi Sankyo, the companies said on Thursday.
The pill is widely considered the most important experimental medicine in Lilly’s pipeline, and its shares rose nearly 3 percent on the news.
A priority review means the Food and Drug Administration likely will decide within six months whether to approve the drug, known generically as prasugrel, rather than the usual 10- to 12-month review period.
If approved, the drug would compete with Plavix, a blockbuster drug sold by Bristol-Myers Squibb Co and Sanofi-Aventis.
“Getting priority review is a positive. Not getting it would have raised some caution,” said Tim Anderson, an analyst for Sanford Bernstein.
Anderson, who said he was surprised by the decision, said he still believes the drug will have to go before an advisory panel of experts before the FDA makes its decision.
Mixed data on prasugrel were unveiled in November from a study of heart patients slated to receive stents — tiny tubes that prop open coronary arteries after they have been cleared of plaque.
In that study, prasugrel was 19 percent more effective than Plavix in preventing cardiovascular death, nonfatal heart attacks and strokes, but caused a significantly higher amount of serious bleeding.
The companies filed their application for prasugrel on December 26. If approved, Lilly said the drug’s brand name would be Effient.
Shares of Eli Lilly rose 2.9 percent, or $1.43, to $51.25 in after-hours trading following the news. They had closed at $49.82 on the New York Stock Exchange.
Reporting by Lisa Richwine, additional reporting by Bill Berkrot in New York, editing by Gunna Dickson, Gary Hill