Boehringer bags FDA approval for Spiriva-based combo

Boehringer Ingelheim has won US approval for Stiolto, a combination therapy for chronic obstructive pulmonary disease (COPD) that extends its big-selling Spiriva franchise.

Stiolto contains the active ingredient in Spiriva - long-acting muscarinic antagonist (LAMA) tiotropium - with long-acting beta agonist (LABA) olodaterol that is sold as a monotherapy under the Striverdi brand name. The combination has been approved by the FDA as a once-daily maintenance therapy for COPD.

The combination of olodaterol and tiotropium significantly improved lung function compared with either drug alone in clinical trials involving more than 5000 individuals, according to the US regulator.

Spiriva is already one of the biggest-selling drugs for COPD in the world with sales of €3.2bn last year, but is facing increased competition as the treatment of COPD shifts towards LAMA/LABA combination therapy and is due to lose patent protection in the US in 2018.

Stiolto is being positioned as a successor to Spiriva, and is the second LAMA/LABA combination to reach the US market after GlaxoSmithKline's Anoro (umeclidinium bromide/vilanterol), and is an important new drug for Boehringer given that Spiriva is already showing signs of weakness with sales down 9% last year.

"Stiolto …provides even further benefits than Spiriva alone and will offer a valuable new treatment option for patients and physicians," said Boehringer's chief medical officer Klaus Dugi. 

"We look forward to the decision from the European regulatory authorities soon," he added.

Competition is only expected to increase further in COPD. For example, Novartis is due to enter the US LAMA/LABA category shortly with its QVA149 (glycopyrronium bromide/indacaterol) product, which is already available in Europe under the Ultibro brand name. AstraZeneca is also bringing its aclidinium bromide/formoterol fumarate product -sold in Europe as Duaklir - through the latter stages of development.

Decision Resources (DR) has predicted that LAMA/LABA combinations will capture more than 35% of a COPD market tipped to reach $14bn in the top seven pharma markets alone by 2022, up from around $10bn in 2012. 

The class will displace Spiriva and other top sellers such as GSK's beta agonist/corticosteroid combination Advair/Seretide (salmeterol/fluticasone), but will have to share the market, with smaller sales individually than their multibillion-dollar predecessors.

Meanwhile, there is also speculation that LAMA/LABAs themselves will eventually be superseded by triple therapy, with an inhaled corticosteroid added to the mix, with GSK considered to be leading the charge with its 10,000-patient FULFIL trial of Anoro plus fluticasone.