Bristol-Myers Seeks Approval of Anti-AIDS Drug

Bristol-Myers Squibb Co. said it has filed for government permission to market the anti-AIDS drug known as ddI, which would become the second approved therapy that slows the progression of AIDS.

The drug, also known as didanosine and by the brand name Videx, is similar to AZT, the only drug approved by the Food and Drug Administration to treat acquired immune deficiency syndrome.

Both drugs work by inhibiting an enzyme that the AIDS virus needs to grow, the company said.

AIDS activists have been pushing for speedy approval of ddI, which the company said has been administered to more than 23,000 patients worldwide in clinical studies and through an expanded use program that allows doctors to give the drug to AIDS carriers who do not respond to AZT treatments.

Under the expanded access program, ddI is available to patients who are in critical need but do not qualify for clinical trials, the company said.

AIDS activists called on the FDA to make a decision on ddI as quickly as possible.

“It’s high time that some other drugs came down the pipe,” said Mark Harrington of AIDS Coalition to Unleash Power, or ACT UP, in New York. “Let’s hope it starts a price war.”