logo
Share SHARE
FONT-SIZE Plus   Neg

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

Swiss pharmaceutical giant Novartis AG (NVS) 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
Best Buy announced Wednesday its plans to introduce Amazon Alexa and Google Home experiences to its 700 locations across the U.S. starting next month as part of its strategy of pushing smart home technology. A nationwide rollout will be complete by the end of the year. The electronics retailer will expand space at selected stores to better showcase how Amazon's Echo and Google Home interact.. So far this year, 23 novel drugs have already received FDA approval. Now let's take a look at the biotech stocks waiting to hear from the FDA in July. President Donald Trump has continued his assault on one of his favorite targets on Wednesday, lashing out at major media outlets in a series of posts on Twitter. Trump singled out the New York Times and the Washington Post in his tweets, describing the newspapers as "fake news."
comments powered by Disqus
Follow RTT