FONT-SIZE Plus   Neg

Bristol-Myers Squibb Says FDA Oks Supplemental NDA For SUSTIVA - Quick Facts

Bristol-Myers Squibb Company (BMY), a biopharmaceutical company, Friday said the US Food And Drug Administration, or FDA, approved a supplemental new drug application or sNDA for SUSTIVA, 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-naïve 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.

SUSTIVA is a non-nucleoside reverse transcriptase inhibitor or NNRTI that was originally approved in the U.S. in 1998 to treat HIV-1 infected children three years of age or older and weighing at least 10 kg.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
comScore (SCOR), a global media measurement and analytics company, reported U.S. desktop retail e-commerce spending for the first 27 days of the November-December 2015 holiday season. For the holiday season-to-date, $23.4 billion has been spent online, marking a 5-percent increase versus the corresponding... Cricket Wireless Monday said it is adding to the Cyber Monday excitement by offering new and existing customers 50 percent off Samsung Galaxy S4, S5, and S6 today through December 3 with activation on a smartphone plan. The offer can be combined with the Black Friday offer where customers switching... Global watch maker, Swatch Group will be launching "pay by the wrist" watches early next year in partnership with Visa Inc.
comments powered by Disqus
Follow RTT