Boehringer Ingelheim’s combination lung drug Spiolto has been approved in its first European countries, including the UK, for the treatment of chronic obstructive pulmonary disease (COPD) _
It is being touted as a successor to the company’s aging blockbuster Spiriva (tiotropium), but it enters a far more crowded market than its predecessor faced.
The drug combines Spiriva, a long acting muscarinic antagonist (LAMA), with long-acting _2-adrenergic agonist (LABA) olodaterol – sold as a monotherapy under the brand name Striverdi. It is delivered through the Respimat mist inhaler, which is designed to allow for more natural inhalation than standard devices.
It was approved by the FDA in May and has now been given the green light in nine European countries – UK, Ireland Croatia, Slovakia, Denmark, Norway, Austria, Romania and Spain. _
The approval is based on trials that tested the drug against Spiriva and found that it led to ‘significant’ improvement in lung function – including more than doubling lung function in patients who had no prior maintenance therapy.
But it is not the only LAMA/LABA combination COPD therapy on the market in the EU. It has been beaten to the post by GlaxoSmithKline’s Anoro (umeclidinium/vilantero) and Novartis’ Ultibro (indacaterol/glycopyrronium)
And even these medicines may soon be replaced by triple combination therapies that combine LAMA and LABA drugs with corticosteroids. GSK began trials of such a treatment in February.
But speaking to PharmaTimes, Lars Groenke, team leader of respiratory medical affairs at Boerhinger, says that he is not worried that triple therapies may soon make Spiolto obsolete.
“You’ll see from our current portfolio that Boehringer is not the biggest believer in corticosteroids in COPD. Part of this is based on studies where we have shown that Spiriva and a LABA reduce the corticosteroid component in patients. At least we don’t see what some people would have expected to see some years ago, that you have an increase in the exacerbation rate.
“Now, is there a place for triple therapy? I think that is a very good question and it’s a question that GSK and AstraZeneca and others are setting out to answer. We will be very interested in what their study results are.
“We do believe that if you have a patient on Spiolto this will carry them for quite some time, and for me the next question is which patient will really benefit from an upgrade to a triple. If you say that, for example, triple combination will reduce exacerbation rates by 8%, is that still meaningful? So yes, I believe that triple therapy is an option for some patients, but I don’t believe it’s that many to be honest. Unfortunately at the moment I don’t think anybody can tell you who’s going to benefit from it.”
COPD is a chronic, progressive, treatable but incurable lung disease that is predicted by the World Health Organization to become the third leading cause of death worldwide by 2030. Symptoms include breathlessness and coughing that prevent patients from being active.