14:17 Eli Lilly's prasugrel could face FDA advisory committee panel; slight chance for additional trial, cardiologists speculate
Story Eli Lilly's prasugrel may face an increased chance of review from an FDA advisory committee as the agency continues to delay approval, cardiologists said.
The blood thinner, which Eli Lilly is counting on to compete against Bristol-Myers Squibb and Sanofi-Aventis’ Plavix (clopidogrel), has been plagued by multiple delays since the original PDUFA date of 26 June. The most recent delay came following the 26 September PDUFA date, which came and went without any word from the agency as to how long it would need to make a decision.
The delays hold particular importance for Eli Lilly because Plavix may lose its patent protection as early as 2011, forcing prasugrel to compete against cheaper generic clopidogrel.
Somewhat unexpectedly, the drug never came up before an agency advisory committee before its PDUFA date, and no explanation was given. But cardiologists said the delay may signal some difficulties the agency was having as it examined the NDA, increasing the likelihood an advisory panel would deal with the drug this time around. It is also unclear whether the FDA believes prasugrel can effectively be managed by a Risk Evaluation and Mitigation Strategy (REMS).
Dr Antonio Gotto, who is an authority in the field of cardiovascular medicine and dean of Weill Cornell Medical College, said he believed the odds of an advisory committee have increased significantly since the latest delay. Gotto said it was possible the agency would ask for more data from the company, but given the amount of data on hand he believes the agency is likely grappling with how to deal with the increased bleeding risk.
In the pivotal Phase III TRITON-TIMI 38 study, patients who took prasugrel reduced the risk of cardiovascular death, non-fatal heart attacks, or non-fatal strokes by 19% when compared to Plavix. Cardiologists interviewed by this news service also cited the 50% reduction in stent thrombosis for prasugrel when compared to Plavix.
On 26 September, Eli Lilly released a statement concerning the delay. "We remain engaged in collaborative and productive discussions with the FDA regarding the details of our application. This is a very large, complex submission, and it should not be surprising that delays occur," Jennifer Stotka, MD and vice president for Global Regulatory Affairs said in the statement. "Daiichi Sankyo and Lilly will not speculate on the timing or what the outcome will be. However, the review is very far along, and we remain optimistic." A spokesperson for the company said there was no further update on the drug’s status.
Dr James Wilson, a cardiologist at St. Luke’s Hospital in Houston, Texas, said he felt there was plenty of data to warrant approval, but that an advisory committee would likely be asked to look at the data to help the agency deal with any label warnings. “That’s probably what’s going to happen, they’ll kick it back and say please give us some recommendations on what to do with this one,” Wilson said.
Dr Eric Bates, a site investigator for the drug and a cardiologist at the University of Michigan, said the agency could be looking at the groups in which the bleeding risk showed up: patients over the age of 74, weighing under 60 kg, or those with a previous neurologic event. He said it was possible the agency could ask for another trial, excluding the at-risk groups. But Bates still believed the drug had proved efficacy, and that the risk-benefit ratio merited approval.
Bates said prasugrel would get “approved in some capacity,” but remained uncertain over the drug’s bleeding risk, and whether it would be labeled with a black box or not.
While all cardiologists agreed there was a slight chance the agency would require another trial from the company, they agreed there was sufficient data to approve the drug with warning labels that highlighted the bleeding risk. They also pointed to the unusually large NDA for the drug, which could help explain at least some of the delay. All cardiologists interviewed by this news service said they believed prasugrel should be approved.
Dr Bonnie Weiner, past president of the Society for Cardiovascular Angiography and Interventions (SCAI), said that while it was possible another trial could be required, it is more likely the agency would simply approve the drug with the at-risk populations excluded. “Certainly looking at what’s been published, this would potentially be a drug that would be a valuable addition to the choices we have for patients. That’s the bottom line,” Weiner said.
Eli Lilly has a market cap of USD 50.46bn.
by Marc Longpre
Source Pharmawire
AI
