Fujisawa Healthcare, Inc. and Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA)
approved the antifungal drug AmBisome ((amphotericin B) liposome
for injection) for the treatment of cryptococcal meningitis in
HIV-infected patients. Fujisawa submitted a supplemental New Drug
Application (sNDA) for AmBisome in July 1999 seeking a label expansion
for the additional indication.
"The FDA's approval of this submission makes AmBisome the first
lipid agent to receive an indication for cryptococcal meningitis in
HIV-infected patients," stated Noboru Maeda, chairman and chief
executive officer of Fujisawa. "This is a significant approval for
Fujisawa as we strive to become the best in the therapeutic class."
Cryptococcal meningitis, a life-threatening infection of the
membranes that line the brain and spinal cord (meninges), can occur
when a patient is exposed to the fungus Cryptococcus neoformans. The
organism can infect almost all organs in the body, although 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 percent of these patients.
In February, the FDA approved a labeling supplement for AmBisome
that provided data comparing the safety of AmBisome with Abelcet
(amphotericin B lipid complex, produced by The Liposome Company). As a
result, the AmBisome label now includes a claim of superior safety
compared to Abelcet in febrile neutropenic cancer patients. Despite
the fact that those patients in the clinical trial who received
AmBisome had significantly less nephrotoxicity, dose-limiting renal
toxicity may still be observed with AmBisome.
AmBisome is a unilamellar (single-layer) 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 (treatment based upon the clinical
symptoms of a patient, rather than the results of culture tests) 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.
Additionally, AmBisome is recommended for the treatment of patients
where renal impairment or unacceptable toxicity suggests that
conventional amphotericin B should not be used or should be
About Fujisawa and Gilead
Fujisawa Healthcare, Inc., headquartered in Deerfield, IL,
develops, manufactures, and markets proprietary pharmaceutical
products in the United States and abroad. Fujisawa Healthcare, Inc. is
a subsidiary of Fujisawa Pharmaceutical Co., Ltd., based in Osaka,
Japan. Fujisawa Pharmaceutical Co., Ltd., founded in 1894, is a
leading pharmaceutical manufacturer with international operations in
North America, Europe, and Asia. Additional information on Fujisawa
Healthcare, Inc. and its products can be found on the Internet at www.fujisawa.com.
Gilead Sciences, headquartered in Foster City, CA, is an
independent biopharmaceutical company that seeks to provide
accelerated solutions for patients and the people who care for them.
The Company discovers, develops, manufactures and commercializes
proprietary therapeutics for challenging infectious diseases (viral,
fungal and bacterial infections) and cancer. Gilead maintains
research, development or manufacturing facilities in Foster City, CA;
Boulder, CO; San Dimas, CA; Cambridge, UK; and Dublin, Ireland and
sales and marketing organizations in the United States, Europe, and
Australia. For more information about Gilead, visit the Company's Web
site at www.gilead.com.