Rifabutin Approval

Date: December 23, 1992
Source: Food and Drug Administration (FDA)

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 noÔ status must have demonstrated through clinical testing that they may be efficacious.

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 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 Dr. Feigal.

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.