BURROUGHS WELLCOME: FDA ADVISORY COMMITTEE RECOMMENDS APPROVAL OF MARKETING OF ZOVIRAX FOR CHICKENPOX
BURROUGHS WELLCOME: FDA ADVISORY COMMITTEE RECOMMENDS
APPROVAL OF MARKETING OF ZOVIRAX FOR CHICKENPOX
RESEARCH TRIANGLE PARK, N.C., Nov. 12 /PRNewswire/ -- The Food and Drug Administration's Antiviral Drug Advisory Committee has recommended that FDA labeling for the Burroughs Wellcome Co. drug Zovirax brand acyclovir be expanded to include use of the drug for the treatment of chickenpox in otherwise healthy children and adolescents 2-18 years of age. The committee, made up of outside experts, made its recommendations after reviewing and evaluating the available data on the drug's use in this patient population.
The committee voted to approve the drug with two abstentions.
The committee's recommendations, while not binding on FDA, will be part of the consideration in reviewing the supplemental new drug application (NDA) for Zovirax submitted by Burroughs Wellcome Co., a research-based pharmaceutical company headquartered in Research Triangle Park, N.C.
Nearly 1,000 children and adolescents in the United States have received therapy with Zovirax for chickenpox through a clinical trial program which began in 1987.
The data presented to the Advisory Committee indicated that patients treated with Zovirax experienced onset of cutaneous healing sooner, had fewer skin lesions and constitutional symptoms resolved more quickly. The committee noted that the data did not identify a sub-group of patients that would be most likely to benefit and recommended that additional guidelines for appropriate use be developed. Adverse events were infrequent and not statistically different among patients treated with placebo or acyclovir.
Zovirax was developed as a part of Burroughs Wellcome's antiviral research program. The drug is the first antiviral medication selective enough to be used routinely and systematically to combat several of the herpesvirus infections. In 1982, Burroughs Wellcome Co. introduced Zovirax Ointment, the first drug released for marketing in the United States to treat initial episodes of genital herpes. Zovirax Capsules were introduced in 1985 for treatment of initial disease and for treatment and suppression of recurrent genital herpes. Zovirax Suspension was introduced in 1989. In 1990, the indications for Zovirax were expanded to include treatment of herpes zoster (shingles) with oral and I.V. preparations and I.V. therapy for herpes simplex encephalitis.
/CONTACT: Sharon Haggerty of Burroughs Wellcome, 919-248-8611/ CO: Burroughs Wellcome Co. ST: North Carolina IN: MTC SU: KD-JT -- NY088 -- 3671 11/12/91 17:41 EST