With a new FDA nod, Novartis enters a crowded COPD field

Novartis ($NVS) won FDA approval for a combination COPD treatment it hopes can steal market share from entrenched rivals GlaxoSmithKline ($GSK) and Boehringer Ingelheim, planning to launch the inhaler next year.

The FDA signed off on QVA149, a combination of the bronchodilating agents indacaterol and glycopyrrolate, which Novartis plans to market as Utibron Neohaler. In Phase III development, 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 expects to launch its new treatment in the first quarter of 2016, wading into a market already crowded with next-generation inhalers.

GSK launched the U.S.'s first combo COPD treatment last year with Anoro Ellipta, followed by Boehringer and its Stiolto Respimat. And AstraZeneca ($AZN) is not far behind with a similar treatment of its own, posting positive Phase III results for the in-development PT003 in March and planning to file for global approvals later this year.

Despite trailing its rivals in the U.S., Novartis believes its product can stand out in the crowded space, carving out a substantial share of a market expected to reach about $14 billion in 2018. And while GSK is the first mover, the company has so far struggled to live up to analysts' expectations with Anoro and Breo Ellipta, therapies it hopes will eventually make up for Advair's roughly $8 billion in annual revenue.

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