Boehringer snags FDA approval for COPD combo drug

Boehringer Ingelheim picked up FDA approval for a next-generation COPD treatment, looking to contend for a share of the fast-crowding market for combination therapies.

The inhaled treatment combines olodaterol, approved in July as Striverdi, with tiotropium, on sale as Spiriva, to create a two-in-one drug called Stiolto Respimat. Olodaterol is a long-acting beta2 agonist (LABA), while tiotropium is a long-acting muscarinic antagonist (LAMA), and in two 52-week Phase III trials on more than 5,500 COPD patients, the tandem better improved lung function than each agent on its own, Boehringer said.

The combination is now cleared to treat COPD, including chronic bronchitis and emphysema, and, like all LABA drugs, carries a warning of increased risk of asthma-related death.

Meanwhile, GlaxoSmithKline ($GSK) is already on the market with Anoro Ellipta, which combines proprietary LABA and LAMA treatments. And AstraZeneca ($AZN) is not far behind with a combo 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. Novartis ($NVS) is working to get the similar QVA149, already approved in Europe, onto the U.S. market, submitting the inhaler for approval in December.

The arrival of so many new treatments is expected to shift the landscape for COPD medicines, pushing the global market from $10 billion in 2013 to $14 billion in 2018, according to Citi.

- read the statement

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