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Kynapid: A matter of benefit

Regulation

Kynapid: A matter of benefit

Once it resolved existential questions about the role of drugs in treating atrial fibrillation, the Cardiovascular and Renal Drugs Advisory Committee's deliberations on Kynapid vernakalant from Cardiome Pharma Corp. and Astellas Pharma Inc. came down to a straightforward risk-benefit calculation in favor of approval.

Last week's meeting was dominated by debates about the benefits of using any drug to rapidly convert AF to sinus rhythm, and the acceptability of short-term endpoints to demonstrate efficacy(see Cover Story).But while changing views within FDA about these basic issues have made a moving target of Kynapid's approval requirements, the committee's 6-2 vote to recommend approval may stabilize the regulatory foundation under the product.

If FDA adheres to the recommendation, Kynapid is likely to be widely used to treat the condition, according to advisory committee members.

Getting to data

Kynapid, a mixed ion channel antagonist, was developed by Cardiome (TSX:COM; CRME, Vancouver, B.C.) and Astellas (Tokyo:4503, Tokyo, Japan).

Astellas has North American rights, conducted one of the Phase III trials that provide efficacy data for the NDA, and is responsible for U.S. regulatory activities.

COM and Astellas have completed two Phase II trials and the ACT I and III Phase III trials of Kynapid. In addition,

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