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Bristol-Myers Squibb Co Receives US FDA sNDA Approval For Use Of SUSTIVA (efavirenz) In HIV-1 Infected Pediatric Patients


Friday, 3 May 2013 08:00am EDT 

Bristol-Myers Squibb Co announced that the U.S. Food and Drug Administration (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 3.5 kg. This approval offers 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. This sNDA was based on results from three open-label studies that evaluated the pharmacokinetics, safety, and antiretroviral activity of SUSTIVA in combination with other antiretroviral agents in 182 antiretroviral-na├»ve and -experienced HIV-1 infected pediatric patients (three 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. The adverse reactions observed in the three pediatric trials were similar to those observed in clinical trials in adults, except that rash was more common in pediatric patients (32% for all grades regardless of causality) and more often of higher grade (i.e., more severe). Five pediatric patients (2.7%) discontinued from the study because of rash. 

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