Novartis ($NVS), working to get a pair of Europe-approved COPD treatments onto the U.S. market, reported some positive Phase III data while awaiting final word from the FDA.
The two inhaled treatments are NVA237, a bronchodilator marketed as Seebri Breezhaler overseas, and QVA149, which combines the active ingredient in NVA237 with Novartis' approved Onbrez.
In one Phase III program, the twice-daily QVA149 met its goals of significantly improving COPD patients' lung function compared to placebo and its individual components alone. The inhaler also met its secondary goals of improving breathlessness and quality of life, Novartis said. And in two separate late-stage studies, NVA237 beat placebo in improving lung function, meeting its primary endpoint. Both treatments charted a similar profile to placebo and their comparator agents, the company said.
http://www.fiercebiotech.com/story/novartis-duo-copd-drugs-clears-phase-iii-path-fda-decision/2015-05-22
In one Phase III program, the twice-daily QVA149 met its goals of significantly improving COPD patients' lung function compared to placebo and its individual components alone. The inhaler also met its secondary goals of improving breathlessness and quality of life, Novartis said. And in two separate late-stage studies, NVA237 beat placebo in improving lung function, meeting its primary endpoint. Both treatments charted a similar profile to placebo and their comparator agents, the company said.
http://www.fiercebiotech.com/story/novartis-duo-copd-drugs-clears-phase-iii-path-fda-decision/2015-05-22
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