Approval likely for dabigatran as FDA posts positive briefing documents for advisory panel

A positive recommendation for dabigatran appears likely based on the extremely benign briefing documents posted by the FDA in preparation for Monday’s meeting of the Cardiovascular and Renal Drugs Advisory Committee. The panel will discuss the NDA for dabigatran (Pradaxa, Boehringer Ingelheim) for the prevention of stroke in patients with AF.

The conclusions and recommendations of the reviewers suggest that panel members will have an easy time approving the drug. The hard work for the day will involve dosing issues and the precise language for the drug’s label.

The clinical review has this recommendation:

Dabigatran should be approved for the prevention of stroke and systemic embolism in patients with atrial fibrillation. The 150 mg dose of dabigatran should be approved but not the 110 mg dose. A superiority claim over warfarin should not be granted.

Several reviewers pointed out that a higher dose of dabigatran may be even more effective and as safe as warfarin, and urged that the company perform a clinical trial with this dose. The statistical reviewer termed the findings of RE-LY “very robust.”

An addendum to the clinical review raises a new concern about a higher rate of MI in the RE-LY trial for patients on dabigatran, but this does not appear to be likely to be a roadblock to approval. The reviewer “recommends describing the higher rate of MI with dabigatran in the label,” and notes that the ongoing trials with dabigatran in ACS “will likely provide a more definitive answer to this question.”

The acting chair of the panel will be A. Michael Lincoff. His boss at the Cleveland Clinic, Steve Nissen, will also be a voting member, as will Sanjay Kaul and Darren McGuire. I would expect that Nissen will want to demonstrate that he’s no Dr. No and though he may ask some hard questions I would predict that he will agree with most of the panel and recommend approval.

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