Boehringer Ingelheim has submitted its combination respiratory drug to the European Medicines Agency (EMA) for approval.
The regulator will now decide if it will assess the combination of tiotropium and olodaterol for use in the treatment of chronic obstructive pulmonary disease (COPD) based on the data provided by Boehringer.
The drug combines Boehringer’s huge selling Spiriva (tiotropium) with another of its respiratory treatments Striverdi (olodaterol).
Spiriva is among the world’s biggest selling drugs, with revenues of almost $5bn for 2013. However, it is due to lose patent protection soon, and Boehringer is looking at ways to extend the life of the franchise.
Striverdi is yet to hit the same lofty heights as Spiriva, having only received approval earlier this year.
Boehringer has its hopes set on the potential of a combination therapy, with Spiriva a COPD maintenance therapy and Striverdi a once-daily and fast-acting long-acting beta agonist (LABA).
“The fixed-dose combination of tiotropium and olodaterol represents another major advance from our robust respiratory portfolio,” said professor Klaus Dugi, chief medical officer, Boehringer.
“Once approved, we believe it will make an important contribution to addressing the current unmet needs of the millions of patients whose ability to lead a full life is disrupted by COPD.”
Boehringer has reported positive late stage data on the combination therapy, which demonstrated the combo was effective in improving lung function in COPD patients than placebo or either of the two drugs given as a monotherapy over a six-week period.
Other combinations with COPD combinations either approved or in the works include GSK and Novartis.