BURROUGHS WELLCOME AZT TREATMENT IND PROTOCOL WAS SUBMITTED TO FDA SEPT. 26

Executive Summary

BURROUGHS WELLCOME AZT TREATMENT IND PROTOCOL WAS SUBMITTED TO FDA SEPT. 26, the firm said. The protocol was submitted exactly one week after HHS and Burroughs Wellcome announced the compound would be made available on a treatment IND basis to AIDS patients who have had pnuemocystis carinii ("The Pink Sheet" Sept. 22, p. 3). The protocol, which is being evaluated by FDA's Division of Anti-Infective Drug Products, defines the precise group of AIDS patients eligible to receive the drug. FDA has reportedly taken an active role in advising Burroughs Wellcome of the appropriate eligibility criteria for the protocol to facilitate a speedy review of the application. Burroughs Wellcome said it will not disclose the proposed eligibilty criteria for the treatment IND until FDA clears the application. FDA recently announced that it has classified AZT (azidothymidine) as a 1AA drug, to indicate that it has "absolute top priority" for agency review. FDA normally classifies a new chemical entity with important therapeutic gain as a 1A drug. Reporting on the status of AZT, National Institute of Allergy and Infectious Diseases Director Anthony Fauci, MD, told the Institute's advisory council Sept. 25 that the proposed dosage tentatively agreed to by FDA and Burroughs Wellcome is 200 mg every four hours for the first month of treatment and 100 mg every four hours thereafter. Noting that the dose is lower than that used in Burroughs Wellcome's clinical trial, Fauci said "different doses will be studied in protocols that are now being designed or being modified." Discussing distribution plans for the antiviral, Fauci said that Rockville, Maryland-based Biospherics will, upon request, send doctors, patients, and pharmacies information packets on the procedure for receiving treatment. Doctors, for example, will be sent entry criteria and the necessary information for enrolling a patient. Fauci said that physicians would then submit the applications to an "authorizing committee" made up of a panel of physicians which would determine whether or not patients meet the entry criteria of the treatment IND. If the patient is approved, "then the authorizing committee notifies the doctor that the patient is approved, notifies Burroughs Welcome, identifying the patient, [and] Burroughs Wellcome ships to the appropriate pharmacy the drug for that patient," Fauci said. The NIAID director noted that only registered hospital pharmacies would be handling the drug so as to "cut down, as best as possible, the black market potential."