Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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

RELATED NEWS
Trade NVS now with 

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Policymakers of Reserve Bank of Australia decided to maintain its record low interest rate once again as they continue to assess that the most prudent course is a period of stability in interest rates. The monetary policy board retained the cash rate at 2.50 percent. The rate has been at the current level since August 2013. A ban on athletes using stamina-boosting gases - xenon and argon - came into effect on Monday. The World Anti-Doping Agency (WADA) said Hypoxia-Inducible Factor (HIF) activators Xenon and Argon have been added to the 2014 List of Prohibited Substances and Methods List following the required three-month notice period and UNESCO's communication to all States Parties. A recommendation to revise the British manufacturing growth eased further in August to its lowest level in 14 months as output and demand increased at slower rates, survey results from Markit Economics showed Monday. The Markit/CIPS Purchasing Managers' Index dropped to 52.5 from a revised 54.8 in July. Economists had expected the score to fall to 55.1 from July's original figure of 55.4.
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.