Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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

Bristol-Myers Squibb Company (BMY: Quote), 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.

Click here to receive FREE breaking news email alerts for Bristol-Myers Squibb Co. and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Germany's unemployment increased unexpectedly in August as worsening economic activity weighed on job creation. In addition, consumer price inflation, at a four-and-a-half-year low, boosted the scope for more stimulus from the European Central Bank. The number of people out of work increased by a seasonally adjusted 2,000 persons to 2.901 million in August, the Federal Labor Agency reported. NASA has approved the development of the world's most powerful rocket, designed to take humans beyond Earth orbit and to Mars. NASA officials Wednesday announced they have completed a rigorous review of the Space Launch System (SLS) -- the heavy-lift, exploration class rocket under development - and approved the program's progression from formulation to development, something no other exploration Eurozone economic confidence weakened more-than-expected in August to its lowest level in eight months, underscoring rising pessimism amid heightened geopolitical tensions and stagnating economic recovery. The economic confidence index fell to 100.6 in August, the lowest score since December, from 102.1 in July, the European Commission said Thursday.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.