FDA Approves New Indication for Antifungal Medication

The U.S. Food and Drug Administration (FDA) has approved the antifungal drug AmBisome ((amphotericin B) liposome for injection) for the treatment of cryptococcal meningitis in HIV-infected patients. AmBisome is co-marked in the United States by Fujisawa Healthcare Inc. (Deerfield, IL) and Gilead Sciences Inc. (Foster City, CA).

Fujisawa submitted a supplemental New Drug Application (sNDA) for AmBisome in July 1999, seeking a label expansion for the additional indication. According to Noboru Maeda, chairman and CEO of Fujisawa, the approval makes AmBisome the first lipid agent to receive an indication for cryptococcal meningitis in HIV-infected patients.

Cryptococcal meningitis is a life-threatening infection of the membranes that line the brain and spinal cord (meninges). The infection, caused by the fungus Cryptococcus neoformans, can infect almost all organs in the body, but it most commonly causes disease of the meninges, skin, or lungs. The majority of people with cryptococcal meningitis have immune systems that are damaged by disease, such as AIDS, or suppressed by drugs. Cryptococcal meningitis is the most common cryptococcal infection in people infected with HIV, affecting 5-10% of these patients.

AmBisome is a unilamellar liposomal formulation of amphotericin B and is the only true liposomal formulation of this standard of therapy for systemic antifungal therapy. AmBisome is indicated for empirical therapy for presumed fungal infection in febrile, neutropenic patients; in patients with Aspergillus species, Candida species and/or Cryptococcus species infections refractory (non-responsive) to conventional amphotericin B; and for the treatment of visceral leishmaniasis. It is also recommended for the treatment of patients where renal impairment or unacceptable toxicity suggests that conventional amphotericin B should not be used or should be discontinued.

Fujisawa Healthcare develops, manufactures, and markets proprietary pharmaceutical products in the United States and abroad.

Gilead Sciences is an independent biopharmaceutical company that discovers, develops, manufactures, and commercializes proprietary therapeutics for infectious diseases (viral, fungal and bacterial infections) and cancer.

For more information: Fujisawa Healthcare Inc., 3 Pkwy. North, Parkway North Ctr., Deerfield, IL 60015. Tel: 847-317-8800. Fax: 847-317-7296.

Edited by Jim Pomager