Eli Lilly and Tokyo-based Daiichi Sankyo announced Monday that their jointly developed blood thinner, Efient (prasugrel), was approved in Europe for patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI).
Efient will be launching in some European countries as early as April, with more launches scheduled throughout Europe for the rest of the year.
“We’re delighted by the European approval. It’s not only good news for Eli Lilly of course, but more importantly we believe it’s good news for patients in Europe with Acute Coronary Syndromes who are being managed with PCI,” said J. Anthony Ware, vice president for diabetes, cardiovascular, and acute care at Lilly. “We look forward to making this option available to patients with ACS in the European Union in the coming weeks.”
The approval comes after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency issued a positive opinion and recommended approval last December.
Efient works by inhibiting platelet activation through binding its metabolite to platelet receptors, preventing clot formation, clogged arteries, and eventually heart attacks.
In a head-to-head prasugrel-clopidogrel study published in the New England Journal of Medicine in November 2007, patients treated with prasugrel showed a 19 percent relative reduction in death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. But the drop came with an increased risk of fatal bleeding, and US approval was stalled last June in light of these concerns.
Although Effient (as it will be spelled in the United States) approval is still pending in the US, if experience is an indicator, this EU approval bodes well for prasugrel’s chances on this side of the Atlantic. On February 3rd, prasugrel mustered overwhelming support on from Cardiovascular and Renal Drugs Committee when they recommended its authorization with a 9-0 vote.
The concerns over the increased risk of bleeding will also likely affect sales. Decision Resources analyst Graeme Green, expects sales to start off slowly. He predicts that by 2010 total brand sales will be close to $350 million.
Efient will challenge Plavix (clopidogrel), Bristol-Myers Squibb and Sanofi-Aventis’s blood thinning blockbuster, for a slice of the cardiology market.
“Plavix is indicated for a broader population of patients across the full spectrum of ACS, recent MI, recent ischemic stroke, and established P.A.D.,” said Elizabeth Baxter, a spokeswoman for Sanofi-Aventis. “The proven effectiveness and safety profile of Plavix are supported by four large clinical studies involving 81,000 patients.”
Sales Cliff Looming
Plavix has raked in billions of dollars over the past 11 years while enjoying a competition-free sales race. In 2008, Plavix sales reached $8.9 billion, making it second only to Pfizer’s best-selling cholesterol attacker, Lipitor (atorvastatin).
Although competition from Efient is looming, analysts say gashes to Plavix’s sales figures won’t be too deep. While prasugrel will be another option for patients undergoing surgery to unclog their arteries, that particular patient population makes up only a portion of Plavix’s targeted consumers, guaranteeing the veteran a continued tight grip on most of the market.
“Our sales forecasts suggest it’s going to cause a modest dent in Plavix sales, but Plavix sales will be hit,” said Decision Resources analyst Nikhil Mehta. “I think you’ll see a more significant decline in sales from generic versions of Plavix from 2011 in the US.”