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

Teva Receives FDA Approval For Synribo For Injection - Quick Facts

10/26/2012 11:44 AM ET

Teva Pharmaceutical Industries Ltd. (TEVA: Quote) announced Friday that the U.S. Food and Drug Administration or FDA approved Synribo (omacetaxine mepesuccinate) for Injection to treat adult patients with chronic phase or CP or accelerated phase or AP chronic myeloid leukemia or CML with resistance and/or intolerance to two or more tyrosine kinase inhibitors or TKIs.

The indication is based upon response rate. There are no trials verifying an improvement in disease-related symptoms or increased survival with Synribo. It will be available for prescribing shortly.

The company said that the approval is based on an analysis of combined data subsets from two Phase II, open-label, multicenter studies. The pooled analysis included patients who had received 2 or more approved TKIs and, at a minimum, had evidence of resistance or intolerance to dasatinib and/or nilotinib. 47% of CP patients and 63% of AP patients had failed treatment with imatinib, dasatinib, and nilotinib. The majority of patients had also received other treatments including hydroxyurea, interferon, and cytarabine.

synribo will be dosed twice daily for 14 consecutive days of a 28-day cycle at treatment induction, and twice daily for seven consecutive days of a 28-day cycle during maintenance therapy once a response is achieved.

Serious adverse reactions, including myelosuppression, bleeding, and hyperglycemia, have been associated with Synribo. Some reactions, such as myelosuppression and cerebral hemorrhage, have been fatal. Women should be advised to avoid becoming pregnant while using Synribo.

Register
To receive FREE breaking news email alerts for Teva Pharmaceutical Industries Limited and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Intel Corp. said Tuesday after the markets closed that its first quarter profit fell 5% from last year, hurt mainly by higher income tax expenses even as revenue grew slightly. The company's quarterly earnings per share came in above analysts' expectations, but its quarterly revenue fell shy of analysts' forecast. With traders digesting a mixed batch of catalysts, stocks saw considerable volatility over the course of the trading day on Tuesday before closing mostly higher. The gains on the day extended the recovery off the two-month lows set last Friday. The major averages showed a notable rebound in afternoon trading to end the day in positive territory. U.S. President Barack Obama and his Russian counterpart Vladimir Putin spoke regarding the ongoing crisis in Ukraine for the first time in over two weeks on Monday, although the two leaders remain far apart on the cause of escalating tensions.
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.