The FDA approved Boehringer Ingelheim's COPD treatment Striverdi Respimat, a once-a-day inhaler the German drugmaker hopes can contend in a crowded respiratory market.
The treatment, developed as olodaterol, is a long-acting beta2 agonist (LABA) that works to ease airway muscles and prevent symptoms of lung ailments like chronic bronchitis and emphysema. The FDA nod clears Boehringer to market its drug for COPD, the third-leading cause of death in the U.S., and, like other LABA treatments, Striverdi will carry a black-box warning detailing its risks of asthma-related death.
The FDA's blessing follows an October European OK, exposing Boehringer to the world's largest COPD markets, but the company will likely face an uphill battle in a space already flush with next-generation therapies. Last year, a panel of FDA advisers signed off on Striverdi's safety and efficacy but noted little that set it apart from other treatments on the market, including GlaxoSmithKline's ($GSK) soon-to-be-generic Advair.
Meanwhile, GSK has already hit the market with Anoro Ellipta, which combines a proprietary LABA with a separate long-acting muscarinic antagonist (LAMA), part of a new wave of COPD cocktails that analysts expect to eventually dominate the market. And, thanks to its checkbook, AstraZeneca ($AZN) is not far behind, spending $1.5 billion on Pearl Therapeutics and up to $2.1 billion on Almirall's respiratory business to get its hands on some Phase III COPD combos of its own. Novartis' ($NVS) fixed-dose LABA/LAMA, dubbed Ultibro Breezhaler, won European approval last year.
But despite starting from behind, Boehringer believes it can outpace its rivals in COPD. The company is waiting on an FDA nod for a combination of its own, packaging olodaterol with the LAMA bronchodilator tiotropium, which is approved on its own as Spiriva. In top-line Phase III results revealed in May, Boehringer said its combination beat out placebo and each drug on its own in improving lung function at 6 weeks.
And the market might be more penetrable than it once seemed. Despite its first-mover status, GSK has so far struggled to live up to analysts' expectations with Anoro and the recently launched Breo Ellipta, therapies the company hopes will eventually make up for Advair's roughly $8 billion a year in revenue. However, beyond any commercial missteps, GSK remains the global leader in COPD, and it's now working alongside respiratory partner Theravance ($THRX) on a pivotal study of a new daily treatment that pools the three active ingredients found in Anoro and Breo.
COPD affects about 27 million people in the U.S. alone, and Citigroup estimates the market for treatments will jump from $10 billion in 2013 to $14 billion in 2018.
- read the FDA's statement