Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Novartis' Lung Disease Drug QVA149 Meet Primary Endpoints In Phase III Studies

Swiss pharmaceutical giant Novartis AG (NVS: Quote) on Monday said its first three QVA149 Phase III studies in the treatment of chronic obstructive pulmonary disease or COPD all met their primary endpoints.

QVA149, a bronchodilator with dual mode of action, is Novartis' third innovation in its Breezhaler single dose dry powder inhaler.

According to the company, the SHINE, BRIGHT and ENLIGHTEN studies demonstrate the potential of QVA149 in the treatment of COPD. The studies are components of the IGNITE Phase III clinical trial program intended to form the basis for an NDA filing in COPD.

The results of SHINE met the primary endpoint by demonstrating the superiority in trough FEV of once-daily QVA149 compared to once-daily indacaterol or once-daily NVA237 in patients with moderate to severe COPD.

The results of BRIGHT demonstrated that patients experienced significantly better exercise endurance versus placebo and ENLIGHTEN showed that QVA149 was well tolerated with a safety and tolerability profile similar to placebo.

Tim Wright, Head of Development, Novartis Pharmaceuticals, said, "Meeting the primary endpoints in the IGNITE Phase III clinical trial program signals significant progress in establishing the potential of QVA149, which is expected to be the third innovative medicine in our strong COPD portfolio."

The company noted that the data from the IGNITE clinical trial program examining QVA149 in a number of settings will be submitted for presentation to a major medical congress later this year.

Register
To receive FREE breaking news email alerts for Novartis AG and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Apple Inc. said Monday that its fourth quarter profit rose 13% from last year, driven by strong sales of its iPhones and Mac computers. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly sales. At the same time, the company gave an upbeat revenue forecast for the current quarter, which includes the all important holiday season. Stocks moved notably higher over the course of the trading day on Monday, extending the strong upward move seen last Friday. The gains on the day continued the recent recovery by the markets, with the Nasdaq and the S&P 500 closing higher for the third consecutive session. While Republicans have largely tried to frame the upcoming midterm elections as a referendum on President Barack Obama, Sen. Ted Cruz, R-Tex., has joined the few offering guidance on what the GOP will do if it manages to retake control of the Senate.
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.