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Novartis' Ultibro Breezhaler Approved in Europe

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Positive news flowed in at Novartis (NVS - Free Report) when its chronic obstructive pulmonary disease (COPD) drug, Ultibro Breezhaler, gained approval in Europe. Ultibro Breezhaler was approved as a once-daily maintenance bronchodilator treatment to relieve symptoms in adults suffering from COPD.

Moreover, Ultibro inhalation capsules were approved in Japan to relieve various symptoms due to airway obstruction in COPD patients.  Ultibro Breezhaler is a fixed-dose combination of Onbrez Breezhaler and Seebri Breezhaler.

The approval in Europe does not surprise us as Novartis received a positive opinion from the CHMP on Ultibro Breezhaler as a maintenance bronchodilator treatment to relieve symptoms in adults with COPD in Jul 2013.

The approval was based on positive data from a phase III clinical trial, IGNITE. The IGNITE programme included 11 studies and was conducted in over 52 countries by Novartis among 10,000 patients suffering from COPD.

The first eight studies, completed in 2012, showed that Ultibro Breezhaler can significantly improve lung function as compared to several current standard treatments.

The data from the studies also revealed that patients treated with Ultibro Breezhaler showed significant symptomatic improvements in breathlessness, exercise tolerance, rescue medication use and health-related quality of life as compared to placebo.

Meanwhile, Novartis also has another pipeline candidate, BYM338, which is being developed for COPD.

We remind investors that Theravance, Inc. is also developing its COPD candidate in partnership with GlaxoSmithKline (GSK - Free Report) . 

Last week, the CHMP recommended the approval of their candidate fluticasone furoate/vilanterol (proposed brand name: Relvar Ellipta) in Europe for the symptomatic treatment of adults suffering from COPD and asthma. A final decision on the candidate from the European Commission is expected by year end.

Novartis currently carries a Zacks Rank #3 (Hold). Right now, Roche (RHHBY - Free Report) looks attractive with a Zacks Rank #1 (Strong Buy).

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