In Brief: Abbott's Biaxin
Executive Summary
Abbott's Biaxin: Supplemental NDA submitted for Biaxin for prevention of disseminated Mycobacterium avium complex disease in advanced HIV, the company announces May 30. Biaxin (clarithromycin) was given accelerated approval in December 1993 for treatment of MAC. A two-year, double-blind study of 682 patients randomized to either 500 mg clarithromycin or placebo twice daily found the incidence of disseminated MAC was reduced 69% with prophylactic Biaxin use. Mortality from all causes was reduced by 28% ("The Pink Sheet" Oct. 10, 1994, T&G-10)...