A Spiriva-based combination therapy that Boehringer Ingelheim believes will consolidate its position in the chronic obstructive pulmonary disease (COPD) market has been cleared for marketing in nine countries.
Called Spiolto, the new drug combines the active ingredient in Spiriva – long-acting muscarinic antagonist (LAMA) tiotropium – with the long-acting beta agonist (LABA) olodaterol, the active ingredient in the company’s recently launched Striverdi product.
As of the start of this week it had been approved in Croatia, the UK, Slovakia, Denmark, Norway, Ireland, Austria, Romania and Spain, having been given a green light in the US in May under the Stiolto brand name.
Spiriva is Boehringer’s biggest-selling drug – with sales of €3.2bn last year – and along with GlaxoSmithKline’s beta agonist/inhaled corticosteroid (ICS) product Advair/Seretide (salmeterol and fluticasone propionate) accounted for around three quarter of the COPD market in 2013.
Since then, approval of new LAMA/LABA therapies such as Novartis’ Ultibro (glycopyrronium/indacaterol) and GSK’s Anoro (umeclidinium bromide/vilanterol), as well as GSK’s new ICS/LABA therapy Breo/Relvar (fluticasone furoate/vilanterol) which became the first once-daily product of its type, have injected more competition into the marketplace. Meanwhile, Spiriva is due to lose patent protection in the key US market in 2018.
The prevalence of COPD is on the rise globally, it has a massive impact on the health economy and – despite many drug treatments – there remains considerable unmet clinical need, with clinicians desperate to find a regimen that can actually improve mortality in the debilitating condition.
GSK is in the latter stages of a major mortality and morbidity trial of Breo – called SUMMIT – that could allow it to add a mortality claim to the drug’s label and according to analysts would accelerate the use of Breo as well as other newer drugs.
Boehringer notes that Spiolto provides “significant improvements in lung function, breathlessness, quality of life and rescue medication use over Spiriva right from the initial stages when patients need maintenance therapy.”
The company also notes that these additional benefits could enable patients to remain active and avoid the downward spiral of COPD for as long as possible.
“Optimal management right from the start of maintenance therapy may give patients with this highly debilitating lung disease, the best opportunity to stay active, manage their symptoms and have a better quality of life,” says Roland Buhl, head of the pulmonary medicine department at Mainz University Hospital in Germany.
Boehringer is expecting big things from Spiolto, and last year implemented a €35m expansion programme at its Dortmund facility to cater for increased demand for Spiriva and Spiolto.