Food and Drug Administration, U.S. Department of Health and
The Food and Drug Administration today announced the approval
of rifabutin, a drug to prevent Mycobacterium avium complex
(MAC) disease in people with advanced HIV infection.
Rifabutin is the first drug approved for the prevention of MAC
disease. Individuals with MAC infection experience chronic
debilitating symptoms including fever, night sweats, weight
loss, fatigue, abdominal pain, severe anemia and liver
dysfunction. Estimates of its prevalence in patients with
advanced HIV infection range from 30 to 50 percent. In people
with AIDS, this infection can contribute to death.
"As the first product approved for the prevention of MAC
disease, this drug will provide significant benefits for AIDS
patients," said FDA Commissioner David A. Kessler, M.D. "It is
a welcome addition to the growing number of products used to
fight AIDS and diseases that can accompany it."
Patients enrolled in clinical trials who received rifabutin
were one-third to one-half as likely to develop MAC as were
patients who received a placebo.
The most common adverse reactions associated with rifabutin are
rash, gastrointestinal symptoms, muscle and joint aches and
discolored urine. In the trials, a decrease in certain
infection-fighting white blood cells was the only serious
adverse reaction that occurred in more patients who received
rifabutin than patients who received a placebo.
Rifabutin was made available in February under a Treatment
Investigational New Drug (IND) protocol, under which FDA allows
drug developers to provide pre-approval access to experimental
drugs that are intended to treat serious and life-threatening
conditions for which there are no satisfactory treatments.
Drugs that are granted Treatment IND status must have
demonstrated through clinical testing that they may be
This is the first drug whose approval was based on research
from multi-center clinical trials conducted in community-based
research groups, according to David W. Feigal, Jr., M.D.,
director of the Division of Anti-Viral Drug Products, which is
responsible for reviewing rifabutin. "The approval of rifabutin
marks an important medical advancement for AIDS patients," said
In September, FDA's Antiviral Drug Products Advisory Committee
recommended approval of rifabutin. The committee reviewed data
from two clinical trials involving 1,146 AIDS patients whose
white blood cells or CD4 helper cell counts were 200 or less.
CD4 helper cells are white blood cells important in the immune
system that are destroyed by the AIDS virus.
Rifabutin is manufactured by Adria Laboratories, Columbus,
Ohio, and will be sold under the brand name Mycobutin.