Rethinking AIDS drug approvals

Despite being lauded for its creativity and performance in showing the efficacy of its Viread tenofovir for AIDS, Gilead Sciences Inc. may find itself rewarded by a narrower indication than has been given to competing products as a result of changed regulatory thinking about AIDS therapies.

Members of FDA's Antiviral Drug Products' Advisory Committee and AIDS activists congratulated GILD at last week's panel review of Viread, citing the company's efforts to run trials in patients who have been treated with numerous other drugs - a territory where other companies have declined to tread - rather than in the less challenging population of treatment-naïve patients...