Article reprinted from "The Pink Sheet" DAILY January 6, 2009
As preparations get underway for the Feb. 3 advisory committee review of Lilly and Daiichi Sankyo's platelet inhibitor prasugrel, one indicator of the drug's prospects will be the individuals who are asked by FDA to serve on the expert panel. Read about it here...
Article reprinted from "The Pink Sheet" DAILY January 6, 2009
FDA Confirms Prasugrel Advisory Committee Review; What Will Panel Membership Entail?
As preparations get underway for the Feb. 3 advisory committee review of Lilly and Daiichi Sankyo's platelet inhibitor prasugrel, one indicator of the drug's prospects will be the individuals who are asked by FDA to serve on the expert panel.
The Cardiovascular and Renal Drugs Advisory Committee review will be held Feb. 3 in Silver Spring, Md. While the meeting was not formally announced by FDA until Dec. 31, the agency started contacting committee members this fall about a February meeting.
The confirmation of the advisory committee meeting is a milestone in prasugrel's development, and generally is being viewed by Wall Street analysts and other investors as a sign of life for the beleaguered NDA.
Indeed, the announcement is the first to come out of FDA on prasugrel since June, when the agency extended its review by three months. FDA then let the revised Sept. 26 review deadline pass without an approvability decision.
Three issues understood to be holding up the review are likely to be discussed at the advisory committee: (1) the increase in bleeding among prasugrel patients; (2) an increase risk of colorectal cancer compared to Plavix (clopidogrel) in the TRITON study; and (3) a recent formulation issue either related to the active ingredient or excipient substance.
Handicapping the advisory committee meeting
One major positive indicator for Lilly and Daiichi is that FDA is convening only the Cardio-Renal committee - and not asking for a joint review with the Drug Safety and Risk Management Advisory Committee. A joint meeting would signal significant concerns at FDA regarding prasugrel's safety profile.
Of course, that does not preclude FDA from drawing from members of the Drug Safety and Risk Management Advisory Committee as needed - including its newest member, Public Citizen's Sidney Wolfe, who is unlikely to look kindly upon the NDA (3"The Pink Sheet" DAILY, Oct. 28, 2008).
A number of experts are expected to serve as temporary members, given the vacancies on the Cardio-Renal committee. There are just eight permanent members, including a consumer representative (Consumers Union's Stephen Findlay) and a non-voting industry representative (AstraZeneca's Jonathan Fox).
Indeed, at the committee's last meeting, to review Acusphere's Imagify (perflubutane polymer microspheres), FDA added 13 temporary voting members, including two advisory committee regulars: University of Washington statistician Thomas Fleming and Duke University human cognition expert Ruth Day.
Will Nissen serve?
With a product like prasugrel, one obvious possible choice for a temporary member is Steven Nissen, the head of cardiology at the Cleveland Clinic - an expert on cardiovascular drug safety and a former chair of the Cardio-Renal advisory committee.
Nissen's participation on the committee would be a positive development for Lilly and Daiichi, given that he has come out in favor of prasugrel - first giving the drug a thumbs-up for approval and then criticizing FDA for not delivering an on-time approvability decision.
Speaking at the recent FDA/CMS Summit, Nissen said that Lilly and Daiichi "did a courageous trial against an active comparator and they informed the medical community: What were the benefits? What were the risks? A reasonable and sensible person can look at that and say 'I get it.'"
"The results with prasugrel were a very good result. The drug prevented more myocardial infarctions than the bleeding episodes it caused. I think the drug is an advance."
But those statements may prevent Nissen from serving -especially given FDA's tougher line on conflicts of interest. Indeed, Nissen himself has questioned whether he is qualified to serve on an advisory committee under the new CoI guidelines.
- Kate Rawson
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