LONDON (Reuters) - Eli Lilly & Co (LLY.N) and Daiichi-Sankyo’s (4568.T) new blood clot preventer prasugrel won a major endorsement from international regulators on Thursday when the European Medicines Agency recommended its approval.
A panel of experts at the London-based watchdog said the drug was suitable for use in preventing clots in patients who are to undergo percutaneous coronary intervention, or PCI, a procedure to widen narrowed arteries.
Recommendations for marketing approval by the agency’s Committee for Medicinal Products for Human Use (CHMP) are normally endorsed by the European Commission within a couple of months.
U.S. health regulators have twice delayed a decision on prasugrel, a drug that would compete directly with Plavix, the world’s second-largest selling medicine, which is sold by Bristol-Myers Squibb Co (BMY.N) and Sanofi-Aventis (SASY.PA).
But Daiichi’s head of U.S. commercial operations told Reuters last month he was confident the drug -- which will be marketed as Effient -- would soon win U.S. approval.
The medicine is one of the most keenly awaited in the drugs industry, with some analysts viewing it as a potential blockbuster with multibillion-dollar-a-year sales potential.
The drug is widely considered the most important in Lilly’s developmental pipeline.
There is a debate, however, over how it will be used by doctors, given the risk of bleeding associated with the product.
Like Plavix, prasugrel works by stopping blood cells called platelets from clumping together.
In a pivotal clinical study that pitted prasugrel against Plavix, the Lilly and Daiichi drug was 19 percent more effective than Plavix in preventing cardiovascular death, nonfatal heart attacks and strokes. But it was 32 percent more likely to cause serious bleeding.
Eli Lilly shares were up 54 cents, or 1.5 percent, at $37.48 in early afternoon trade on the New York Stock Exchange.
Editing by Will Waterman and Elaine Hardcastle