Novartis' duo of COPD drugs clears Phase III on the path to an FDA decision

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.

Now Novartis believes it's finally on track to crack the crowded market for next-generation COPD treatments in the U.S. The Swiss drugmaker submitted QVA149 and NVA237 to the FDA in December and expects to get a final word in the second half of this year.

Meanwhile, GlaxoSmithKline ($GSK) is already on the market with the combo COPD treatment Anoro Ellipta, which includes two proprietary bronchodilators. And, thanks to its checkbook, AstraZeneca ($AZN) is not far behind, spending $1.5 billion on Pearl Therapeutics and up to $2.1 billion on Almirall's respiratory business to get its hands on some Phase III COPD combos of its own. Boehringer Ingelheim is at work on a combo therapy as well, awaiting approval for a blend of its Striverdi and Spiriva.

Despite trailing its rivals in the U.S., Novartis believes its products can stand out in the crowded space, carving out a substantial share of a market expected to jump from $10 billion in 2013 to $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 the recently launched Breo Ellipta, therapies it hopes will eventually make up for Advair's roughly $8 billion in annual revenue.

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