Last week the FDA’s Cardiovascular and Renal Drugs Advisory Committee unanimously agreed that Eli Lilly’s clot-buster Effient should be approved for the prevention of thrombosis in several acute coronary syndromes.
The FDA normally follows its panel recommendations, and if so Lilly will at long last have an answer to Plavix, the world’s second leading drug by sales with 2007 revenues in excess of $7 billion.
Plavix is co-marketed by Sanofi-Aventis and Bristol Meyers Squibb. Its patent expires in 2011.
The Committee green-lighted Effient for unstable angina and acute myocardial infarction. It was supposed to vote as well on whether to approve the drug for stent thrombosis prophylaxis, but maybe they had planes to catch.
The Committee’s decision was driven by results from the TRITON-TIMI study, a head-to-head smackdown between Effient and Plavix in which the former proved superior when it came to reducing death from myocardial infarction.
It was saddled with an annoying tendency to kill people via bleeding complications, though.
To deal with the risk-benefit trade-offs, the Committee members recommended that Effient’s go-live should include label warnings regarding the risk of bleeding, especially in those with a history of stroke or who are scheduled for coronary bypass.
There was also a bit of haggling over the excess cancer cases and deaths observed in Effient-treated patients during TRITON-TIMI, but ultimately the committee decided that was a fluke.
In TRITON-TIMI, 33 people who received Effient died of cancer whereas only 21 died in the Plavix group.
But “the trial was not designed to answer questions about cancer. The cancers diagnosed in TRITON are probably coincidental,” William Macias, Lilly’s medical director told MedPageToday.
And the committee tended to agree. “I wouldn’t have a problem giving this drug to a family member, said James Udelson, a Committee member and the chief of cardiology at Tufts.