Cardio panel not converted
FDA advisory committee meetings often focus on narrow technical or statistical issues specific to the compound up for review that can tip the balance between approval or rejection. The agenda for last week's meeting of the Cardiovascular and Renal Drugs Advisory Committee on two proposed therapies for atrial fibrillation went far beyond the usual boundaries to include a wide-ranging discussion about senior FDA officials' doubts about both the clinical value of these therapeutic interventions, as well as the utility of the endpoints used to measure their efficacy.
The heads of the agency's cardiovascular division did not win the support they apparently hoped to get.
The panel unambiguously told FDA there is a role for drugs that can get heart rhythms back to normal in a matter of minutes, thereby alleviating distressing symptoms and avoiding the need for an electric shock that is administered under general anesthesia and often causes serious burns.
The committee members also concluded the endpoints that have served as the basis for previous approvals - and that were used in the applications discussed last week - are acceptable.
Briefings and debate about these fundamental issues set the context for the committee's evaluation of the merits of approving Kynapid vernakalant from Cardiome Pharma Corp. and Astellas Pharma Inc. and Pulzium tedisamil from Solvay S.A.
The deliberations are positive news for developers of drugs for atrial fibrillation (AF). If FDA adopts the committee's advice, it