FDA Panel Withholds Backing For Sorivudine

16 June 1996

A US Food and Drug Administration advisory committee has declined to recommend approval of Bristol-Myers Squibb's antiviral drug Bravavir (sorivudine), on the grounds that although the drug was effective, the potentially fatal drug interactions, which caused sorivudine to be pulled off the market in Japan (Marketletters passim), were a worry.

B-MS was trying to get approval of sorivudine for shingles in immunocompromized patients. The panel decided that although the drug offered efficacy which was "at least" equivalent to Glaxo Wellcome's Zovirax (aciclovir) in this indication) as well offering as the convenience of once-daily dosing, to approve the drug for this non-life-threatening indication was not supportable, particularly as the efficacy is comparable to available therapy.

However, the panel did suggest that there may be specific populations of individuals with life-threatening illnesses who might benefit from the drug. For example, it was suggested that it may be used in immunocompromized patients with retinitis. B-MS has studies of sorivudine ongoing in cancer and transplant patients.

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