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
Best Buy Co., Inc. (BBY) reported first-quarter non-GAAP earnings per share from continuing operations of $0.44, an increase of 19% from $0.37, a year ago. On average, 21 analysts polled by Thomson Reuters expected the company to report profit per share of $0.35 for the quarter. Analysts' estimates typically... Automotive parts retailer AutoZone, Inc. on Tuesday reported a 6 percent increase in profit for the third quarter from last year, reflecting growth in sales and higher inventory on new store openings. However, both revenue and earnings per share for the quarter missed analysts' expectations. Toll Brothers, Inc. (TOL), the nation's leading builder of luxury homes, reported second-quarter net income of $89.1 million, or $0.51 per share, compared to $67.9 million, or $0.37 per share, prior year. Pre-tax income increased to $140.4 million from $86.5 million. On average, 18 analysts polled by...
comments powered by Disqus
Follow RTT