"ROLLING" NDA FOR ADRIA'S RIFABUTIN

A New Drug Application for Adria Laboratories' rifabutin, a product under development as a treatment for opportunistic Mycobacterium avium complex infection in AIDS patients, has been filed with the US Food and Drug Administration. The NDA is being continuously updated as more data becomes available and is added to the submission.

At present, there is no compound which has been specifically approved to treat MAC, and it is generally managed using drugs such as amikacin, ciprofloxacin and clofazamine. However, MAC is only moderately responsive to these treatments. Clinical trials have indicated that rifabutin is effective in preventing or delaying the onset of MAC infections in AIDS patients with CD4 T helper cell counts of 200/mm3 or less. Two double-blind placebo-controlled trials of rifabutin have been carried out.

After interim analysis of the results of the first trial a clear benefit to the patients was observed, whereupon it was deemed unethical to deny rifabutin to those receiving placebo and all patients crossed over to the treatment arm. No such benefit was observed at interim analysis in the second trial, which continued to its endpoint. The final data from this second trial are now under analysis.