Firm Gets Approval to Renew Trials of Drug Aimed at AIDS

The Food and Drug Administration has given ICN Pharmaceuticals of Costa Mesa permission to begin new clinical trials of ribavirin, a drug that the company hopes will be effective in combatting early-stage AIDS.

In doing so, FDA spokesman Brad Stone said, the agency has lifted “a de facto clinical hold” on further human testing of ICN’s proprietary drug ribavirin. The test ban was imposed because of previous FDA concerns about the drug’s safety.

But after reviewing additional data, Stone said, the agency no longer has “concern of sufficient magnitude to prevent further testing.”

The FDA earlier this year denied two separate applications by ICN to allow the use of ribavirin under a special FDA protocol intended to provide promising life-saving drugs to patients during a period in which the drugs are still being assessed for regular commercial distribution.

In denying those requests, the FDA complained that the results of studies conducted by ICN did not show enough evidence of the drug’s “safety and efficacy.”

Since January, 1986, ribavirin has been tested at medical centers throughout the country on 163 patients for treatment of lymphadenopathy, a condition in which the level of white cells in the blood is dramatically reduced, and on 212 patients for treatment of AIDS-related complex (ARC).

Under the go-ahead that the FDA gave ICN last Friday, the company will test ribavirin at New York Hospital-Cornell Medical Center on 32 additional patients who are at high risk of lymphadenopathy or ARC, according to ICN spokesman Jack Sholl.