logo
Share SHARE
FONT-SIZE Plus   Neg

GlaxoSmithKline Receives FDA Approval For PROMACTA

GlaxoSmithKline plc (GSK) Monday said the U.S. Food and Drug Administration has approved PROMACTA for the treatment of low blood platelet counts in patients with chronic hepatitis C.

PROMACTA is the first supportive care treatment available to patients who are ineligible for interferon-based therapy due to their low blood platelet counts.

The approval for PROMACTA was based on results from ENABLE 1 and 2, a two Phase III randomized, double-blind, placebo-controlled, multicenter studies, which collectively enrolled 1,521 patients with lower platelet counts.

"Some chronic hepatitis C patients suffer from low blood platelet counts. Commonly prescribed interferon-based therapies can worsen the problem of low blood platelet counts. Today's FDA approval of PROMACTA gives doctors a tool to address the low platelet challenge, " said Paolo Paoletti, M.D., President, GlaxoSmithKline Oncology.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Several flights to the Indonesian tourist island Bali were canceled due to volcanic ashes from the Mount Raung. Virgin airlines canceled all the flights to Denpasar Airport, while Jetstar rescheduled three flights to Perth and Melbourne in Australia. Activision Blizzard reported a better-than-expected increase in second-quarter profit, as the video game publisher saw robust growth in digital channels, penetration in China and improved margins. It lifted its guidance for 2015, sending its shares up... Diversified media and entertainment conglomerate Walt Disney Co. said Tuesday after the markets closed that its third quarter profit rose 11% from last year, driven mainly by strong earnings growth at its film and consumer products divisions. The company's quarterly earnings per share came in above analysts' expectations, but its quarterly revenue fell short of analysts' forecast.
comments powered by Disqus
RELATED NEWS
Trade GSK now with 
Follow RTT