Yet more good news for Eli Lilly and Daiichi Sankyo has come in the form of full approval in Europe for its highly-anticipated bloodthinner Efient.
The European Commission has granted marketing authorisation for Efient (prasugrel) for the prevention of atherothrombotic events in patients with acute coronary syndrome undergoing percutaneous coronary intervention. The green light was expected as the drug received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency in December.
The approval means that Efient will compete with Sanofi-Aventis/Bristol-Myers Squibb’s blockbuster Plavix (clopidogrel). Data from a head-to-head study showed 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 32% increase in minor and major bleeding.
Takashi Shoda, Daiichi Sankyo chief executive, said that the European approval “is good news for doctors and patients since more than 700,000 people die from heart attacks in the EU each year". He added that Efient will become an important new treatment for patients with ACS undergoing PCI".
The two companies are hoping for approval in the USA soon and earlier this month the Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee voted 9-0 in favour of Efient. However the decision to remove an expert from that committee who had been dubious about the benefits of the drug is causing a stir across the Atlantic.
’Mistake’ to remove expert from FDA prasugrel panel
The FDA has now conceded that it was a “mistake” to withdraw an invitation to Sanjay Kaul, a cardiologist at Cedars-Sinai Heart Institute in Los Angeles, to participate in the prasugrel meeting. Days before the panel would sit, Lilly had questioned Dr Kaul's inclusion because he had authored several papers critical of the treatment.
Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said “at every step of the way there were errors by multiple parties.". She noted that that agency staff who screen panel members only asked Dr Kaul about his financial conflicts of interest, of which he had none, not about any “intellectual bias”.
The latter implies a preference for a “particular interpretation of the data that lacks objectivity and is based on peripheral concerns”, noted Sidney Wolfe, director of Public Citizen’s Health Research Group. He added that “it is unclear how the conclusions Dr Kaul came to regarding the efficacy and safety of prasugrel suggest any bias, as opposed to well-reasoned scientific inquiry. On the contrary, he is free from any financial conflicts of interest, which are not uncommon on FDA Advisory Committees and for which the FDA has an explicit policy to manage”.
Dr Wolfe added that the last-minute removal of Dr Kaul “severely undermined the credibility of the meeting”. Dr Woodcock claimed that the agency does not believe Dr Kaul’s absence from the panel “invalidates the results”. However, as Tim Anderson at Sanford Bernstein noted in an investor’s note, “it would seem to be perfect material” for investigation by critics of the FDA’s procedures.
