Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Cardiome Pharma and Astellas Pharma have reported that the Cardiovascular and Renal Drugs Advisory Committee of the FDA has recommended that the agency approve Kynapid, the intravenous formulation of vernakalant hydrochloride, for rapid conversion of acute atrial fibrillation to sinus rhythm.
Subscribe to our email newsletter
At the panel review, the members voted six to two in favor of recommending to the FDA that Kynapid be approved. An action further to the FDA review of Kynapid is expected on or before January 19, 2008.
William Fitzsimmons, senior vice president of R&D at Astellas, said: “We are pleased with the committee’s recommendation. We strongly believe in the therapeutic value of Kynapid based on clinical trial data and are confident it will be an important therapy for people with atrial fibrillation.”
Bob Rieder, CEO and chairman of Cardiome, said: “We welcome the committee’s recommendation for approval, and look forward to the FDA completing its review and acting on the application early in the new year. People with atrial fibrillation suffer significant disease burden, and we are pleased to move an important step closer to providing doctors with an important tool for meeting this critical unmet medical need.”