Approval aftermath: now the real prasugrel battle begins

Following last Friday’s much anticipated approval of prasugrel, the consensus among observers and analysts is that there is no consensus about the ultimate fate of prasugrel. Given the boxed warning and limited indication, prasugrel will have a hard time capturing the enormous market currently dominated by clopidogrel. Following clopidogrel’s patent expiration prasugrel will then have to prove its cost effectiveness. But Lilly and Daiichi Sankyo are certain to work hard to build a substantial market for their drug.

Here are some of the more interesting comments we’ve found in news stories and blogs:

CNBC’s pharmaceutical reporter, Mike Huckman, reports that Wall Street analysts have expressed some skepticism about the drug’s success. The Miller Tabak analyst said that prasugrel “will not be a major drug,” and the Deutsche Bank analyst dropped her sales forecast by $300 million/year based because of the label.

An article in Forbes by Matt Herper noted that the approval of the lower dose of prasugrel is “a victory for Lilly,” as the dose was not tested in TRITON. “That may lead doctors to use the drug in patients who would otherwise have a higher bleeding risk, such as the underweight.”

Prasugrel is most likely to be adopted by interventional cardiologists, according to two well-known cardiologists,  Howard Weintraub and William Boden, quoted by Herper. Boden is quoted as follows: “I do not see Effient supplanting Plavix for most patients. Plavix has been around for almost 10 years, is effective in most patients, and is largely safe with an acceptable bleeding profile.”

A Datamonitor story published in noted that the companies “had targeted the drug as a replacement for Plavix rather than as a therapy for a niche population. The initial indication in ACS patients undergoing PCI was seen as the first step before entering into the chronic use population for the prevention of venous thromboembolism (VTE), but the restricted label for the drug and the suggestion that prasugrel should only be used in acute settings will severely restrict the potential of the drug.”

An article in the World of DTC Marketing blog made the point that the limited indication and warning label may create a situation in which “physicians who want to use prasugrel off label may find that insurers are not willing to allow use except for label indications. This could lead to a serious confrontation between insurers and HCP’s.”

Finally, Sanjay Kaul, who has been at the eye of the prasugrel storm, said that “overall, the label is faithful to the evidence and consistent with the FDA’s own judgment reflected in its internal review. However, I would like some clarity with regards to the indication. Does thrombotic cardiovascular events include cardiovascular death or nonfatal stroke besides nonfatal myocardial infarction? Or is it confined to nonfatal MI only as implied in the FDA press release? Another point of clarification relates to the claim of superiority over clopidogrel.”

Click here for a complete chronology of the prasugrel controversy.


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  2. […] Some have argued that this boxed warning will make much harder for prasugrel to become a successful drug (in marketing terms). […]

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