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Home Industry News Novartis reports positive clinical trial data for COPD drugs

Novartis reports positive clinical trial data for COPD drugs

9th January 2015

Novartis has announced encouraging data from new clinical trials of two strategically important therapies for chronic obstructive pulmonary disease (COPD).

The new findings from the Expedition and Gem clinical trial programmes are being used to support the company's efforts to secure US regulatory approval for Ultibro Breezhaler and Seebri Breezhaler, both of which are already available in the EU.

Pivotal phase III results showed both therapies were able to meet their primary endpoints and significantly improve lung function in COPD patients, with US-specific studies showing Ultibro Breezhaler demonstrated significant improvements in overall health status compared to placebo.

Applications have been filed with the US Food and Drug Administration seeking approval of both therapies as long-term maintenance treatment options for COPD.

Vasant Narasimhan, global head of development at Novartis Pharmaceuticals, said: "We are closer to offering US patients with COPD a broader range of treatment options to help improve the significant burden of reduced lung function, and to help improve their lives."

In the UK, both therapies have been launched in partnership with Pfizer, as part of an exclusive promotional agreement signed between the companies in September 2014.ADNFCR-8000103-ID-801769434-ADNFCR

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