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ABBOTT's BIAXIN FOR TREATMENT OF MAC WILL GET FDA REVIEW

Executive Summary

ABBOTT's BIAXIN FOR TREATMENT OF MAC WILL GET FDA REVIEW on May 10 by the agency's Antiviral Drugs Advisory Committee. Abbott filed an NDA (50-697) Oct. 30, 1992 for Biaxin (clarithromycin), a macrolide antibiotic licensed from Taisho, for the treatment of Mycobacterium avium complex in people infected with HIV. Biaxin was approved Oct. 31, 1991 for the treatment of sinusitis, pharyngitis/tonsillitis, pneumonia, bronchitis, and skin and skin structure infections. Adria's Mycobutin (rifabutin), approved Dec. 23 for prevention of MAC, is the only approved drug that addresses the bacteremia that is a growing and significant problem in populations with HIV and AIDS. Biaxin would be the first product approved for the active treatment of MAC. An AIDS Clinical Trial Group study (ACTG 157) of 108 people presented at last year's International Conference on Antimicrobial Agents and Chemotherapy meeting in Anaheim found Biaxin to be "highly active as monotherapy for suppressing disseminated MAC bacteremia over 12 weeks" ("The Pink Sheet" Oct. 19, 1992, T&G- 11). The trial also found significant quality of life improvements in people taking Biaxin. The advisory committee on May 11 will review a PLA amendment (92-0747) for Miles' Gamimune N human I.V. immune globulin (IVIG) for prophylaxis of "serious and minor infections in children with HIV" with CD4 cell counts of at least 200 per ml. At the international AIDS conference in Amsterdam last year, a National Institute of Child Health and Human Development study found that IVIG reduced the rate of viral infections in HIV- positive children by one-third and was similarly effective in reducing bacterial infections ("The Pink Sheet" Aug. 3, 1992, T&G- 11). The NICHD study found that IVIG did not reduce opportunistic infections, did not have a beneficial effect in children with CD4 counts of less than 200 and did not have an effect on mortality. The two-day advisory committee meeting will take place at FDA's Parklawn Building, Conference Rooms D & E beginning at 8:30 a.m. May 10 and at 8 a.m. on May 11.
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