Two New Therapies Available Under Treatment IND

The FDA has designated two additional investigational drugs for early availability for use in treatment under its Treatment IND (investigational new drug) program. Altogether 26 drugs have been designated for Treatment INDs since the mechanism was inaugurated in 1987 as a means of providing access prior to marketing approval to promising therapies for serious and life-threatening conditions for which there is no satisfactory alternative treatment. Rifabutin is newly available for use under Treatment IND as prophylaxis against disseminated mycobacterium avium complex (MAC) infection. Rifabutin, a broad-spectrum, antibacterial analog of rifampicin, is to be used for MAC prophylaxis in HIV-positive patients 12 years of age or older with CD4 lymphocyte counts of 200/μL (0.20×10 9 /L) or below. It is administered orally at 300 mg a day. Rifabutin is the first drug for which there are data from controlled trials that may indicate effectiveness in delaying or preventing MAC infections in