Quick Facts
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

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

5/3/2013 8:48 AM ET

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
Justin Moore has been named Humanitarian of the Year by by the Armed Forces Foundation. Moore received the award alongside Big Machine Label Group President/CEO Scott Borchetta for their service and commitment to the morale and welfare of military families through the Crown Royal "Your Hero's Name Here" contest. International Business Machines Corp. said Wednesday after the markets closed that its first quarter profit fell 21% from last year, hurt by lower revenue as well as a hefty workforce rebalancing charge. The company's quarterly earnings per share, excluding items, came in line with analysts' expectations, but its quarterly revenue fell short of analysts' forecast. Stocks moved sharply higher over the course of the trading day on Wednesday, further offsetting the steep losses posted late last week. The markets benefited from a positive reaction to the latest earnings news as well as remarks by Federal Reserve Chairman Janet Yellen. The major averages saw further upside going into the close, ending the session at their best levels of the day.
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.