First Approval Of Nelfinavir: Pediatric Indications Cleared

19 March 1997

The US Food and Drug Administration has approved Agouron's HIV proteaseinhibitor Viracept (nelfinavir mesylate) for use in the treatment of patients with HIV and AIDS. It is the first approval for Viracept worldwide. Viracept is cleared for marketing simultaneously in both adult tablet and pediatric oral powder formulations.

Meantime, Abbott's protease inhibitor Norvir (ritonavir) has also been cleared for pediatric use. Viracept and Norvir are the first drugs in this class to be approved for use in children.

The FDA based its fast-track approval of Viracept on studies which demonstrated that the drug was active in combination with other antiretroviral drugs, or if used alone. In trials involving over 1,000 patients, a mean reduction in viral load of 99% was seen after a period of six months. However, says the FDA, because the antiviral potency of Viracept is increased when used in combination, this form of therapy is recommended. There is no data at the present time to indicate the efficacy of Viracept on the clinical progression of HIV, for example the survival rates or the incidence of opportunistic infections.

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