Bristol-Myers Squibb announced that the FDA has approved a supplemental New Drug Application (sNDA) for Sustiva (efavirenz), including dosing recommendations for HIV-1 infected pediatric patients three months to three years old and weighing at least 3.5kg. The approval provides a once daily option as part of a regimen for this population and includes a “capsule sprinkle” administration method for patients who cannot swallow capsules or tablets.
The sNDA submission was based on results from three open-label studies which evaluated the pharmacokinetics, safety, and antiretroviral activity of Sustiva in combination with other antiretroviral agents in 182 antiretroviral-naïve and -experienced HIV-1 infected pediatric patients (3 months to 21 years of age) for a median of 123 weeks. Virologic and immunologic response was observed across all ages at the end of the studies, as measured by HIV RNA and CD4 cell count.
Sustiva is a non-nucleoside reverse transcriptase inhibitor (NNRTI) already approved to treat HIV-1 infected children three years of age or older and weighing at least 10kg.
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