Regulators in the USA have set a date to review Eli Lilly and Daiichi Sankyo's highly-anticipated bloodthinner prasugrel, which should finally lead to a decision on whether the drug should be approved.

The US Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee will review prasugrel, which the firms hope to market as Efient, during a hearing on February 3. News of the meeting comes after the agency has twice delayed a decision on the investigational antiplatelet agent for the treatment of patients with acute coronary syndromes who have undergone artery-clearing procedures.

John Alexander, Daiichi's global head of R&D, said that “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". Anthony Ware, Lilly’s “cardiovascular platform leader” for the drug, added that "we have full confidence in the data submitted to the FDA and the overall benefit-risk profile of prasugrel”.

Lilly and Daiichi added that they will have further discussions with the FDA in preparation for the committee meeting on prasugrel, which would compete with Sanofi-Aventis/Bristol-Myers Squibb’s blockbuster Plavix (clopidogrel). The data on which the file for Efient is mainly based involves a head-to-head superiority study showing that prasugrel produced a 19% reduction in relative risk for the endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke when compared with Plavix. However, the data also revealed that prasugrel-treated patients experienced a statistically significant 32% increase in minor and major bleeding.

The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval of the drug last month. As for the FDA hearing, analysts believe it is a positive step as it should establish a clear regulatory timeline and resolve uncertainty over the data.