FDA Antiviral Drugs Advisory Committee
Executive Summary
Will review Burroughs Wellcome's Metrone (NDA 20-259) on Sept. 23 for the treatment of Pneumocystic carinii pneumonia in AIDS patients who are intolerant or unresponsive to trimethoprim/sulfamethoxazole. Metrone (atovaquone), previously known as BW 566C80, has been given to approximately 800 patients under a Treatment IND. On Sept. 24, the committee will again discuss Adria's NDA (50-689) for Mycobutin (rifabutin) as a prophylactic agent for Mycobacterium avium infections in AIDS patients. A majority of the committee at its last meeting in June voted to reconsider the drug's clinical data at later meeting to give FDA time to complete its review ("The Pink Sheet" June 8, p. 3). The drug is available under a Treatment IND. The meeting begins at 8 a.m. each day at the Marriott Hotel, 620 Perry Pkwy., Gaithersburg, Md. The committee has scheduled closed deliberations for the afternoon of Sept. 24.