FDA panellists unanimously back Lilly, Daiichi Sankyo’s prasugrel

Eli Lilly and partner Daiichi Sankyo are celebrating following the news that advisers to the US Food and Drug Administratiion have recommended approval for the highly-anticipated bloodthinner prasugrel.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 9-0 in favour of approval for prasugrel, which will be marketed as Effient (Efient in Europe), for the treatment of patients with acute coronary syndromes who have undergone artery-clearing procedures known as percutaneous coronary intervention. If the agency gives the green light, the drug will 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.

However this does not appear to have put off the FDA panellists in terms of the risk/benefit of the drug and Daiichi Sankyo’s head of R&D, John Alexander, said that "we are very proud of the prasugrel data". He noted that the “scientific exchange” with the committee “set the stage for a potential FDA approval of prasugrel, and the future availability of this significant scientific advancement for the treatment of ACS-PCI patients”.

Analysts are not overly convinced, however, that Effient will be afforded the same coverage as Plavix as the FDA may still limit its use because of the bleeding issue, especially among people who had previously had strokes and those over 75. Others, believe it will be a blockbuster and help Lilly counter forthcoming patent expiries on its antipsychotic Zyprexa (olanzapine).

The Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval of the drug in December.