logo
Share SHARE
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
Shares of Marinus Pharmaceuticals Inc. (MRNS) have gained over 35% in the last seven trading days in the run-up to the exploratory phase II study results of Ganaxolone, scheduled for this month. United Parcel Service, Inc. has started to test the use of drones to make commercial deliveries of packages to remote or difficult-to-access locations. On Thursday, the package delivery giant and drone-maker CyPhy Works staged a mock delivery of urgently needed medicine from Beverly, Massachusetts to Children's Island, which is about three miles off the Atlantic coast. Luxury electric car maker Tesla Motors Inc. (TSLA), Thursday filed a lawsuit against state officials over its right to sell vehicles directly to consumers in Michigan. The lawsuit has been filed against Governor Rick Snyder, Secretary of State Ruth Johnson and Attorney General Bill Schuette as defendants. Tesla...
comments powered by Disqus
Follow RTT