Boehringer Ingelheim has secured first European approvals for its new once-daily treatment for chronic obstructive pulmonary disease, Spiolto Respimat

The drug combines the long-acting muscarinic agonist tiotropium – the active ingredient in Spiriva, the world’s most prescribed COPD treatment – with the long-acting beta agonist olodaterol.

Spiriva will be facing generic competition in Europe and the US in the next few years, and the new combination is one tactic Boehringer is using to prolong its dominance in the field.

The German-engineered Respimat technology used in the new inhaler means the drug is delivered to the lungs as a fine mist through a normal breathing pattern, rather than having to take a deep inhalation.

Approvals are based on data from the 5,000 patient TONADO trial, part of a broader programme that showed Spiolto offers significant improvements in lung function among those with both moderate (82 per cent improvement at week 24) and severe disease (68 per cent improvement at week 24) compared to treatment with Spiriva alone. “Spiolto improves lung function to an extent not previously seen with single treatments,” Professor Klaus Rabe of Christian Albrechts University Kiel told the audience at the product’s European launch event.

Many misconceptions surround COPD, most commonly that it is a condition seen only in older men with a history of smoking. Lars Groenke, global medical affairs respiratory at Boehringer Ingelheim, told pharmaphorum that the dynamics of the disease have shifted substantially and COPD is now striking at a younger and, increasingly female population. This is being driven by smoking trends among the ageing baby boomer generation, atmospheric pollution and smoke inhalation from indoor cooking in developing countries. Forty percent of women diagnosed with COPD have never smoked.

But – far from being a death sentence – COPD is now considered to be a treatable condition. In fact, advances in treatment have led experts to cautiously question whether the disease could eventually be reversed.

Emphasising the impact of the disease at the launch event was expert patient ‘Carole’, who told how she had had to give up her career in the police one year after diagnosis, and that the condition severely affects every aspect of her daily life.

Key to halting the disease is earlier, effective diagnosis, which goes hand in hand with the need to educate patients, healthcare professionals and payers about the condition, as well as the substantial public health challenge and economic impact surrounding it. Indeed, the World Health Organisation predicts COPD will be the world’s third biggest cause of death by 2030, killing twice as many people as cancer.

“There is a huge unmet need, and we know not every patient is being treated,” Professor Rabe commented, adding: “The key issue is to improve lung function as we know that an individual’s activity level drives disease outcomes.” This also has a positive bearing on common co-morbidities such as diabetes and cardiovascular disease.

While the market is crowded, products essentially fall into one of three mechanisms of action, so the potential for new modes of treatment to evolve is huge, Lars Groenke told pharmaphorum. Meanwhile, the company is currently in discussions with reimbursement committees to find a pricing solution “that works for everyone,” he added.

Boehringer wants to hold on to its market share by offering the new combination at the same price as the current branded Spiriva.

“We are in the ‘why not’ phase,” noted Groenke. “There are no negative safety signals and no real reason not to use it [Spiolto] … we believe we have a good argument to retain our price point.” He added that the firm would continue to generate data in order to convince health technology assessment bodies that Spiolto adds value to the COPD armamentarium

http://www.pharmaphorum.com/news/boehringer-secures-first-european-approvals-for-new-copd-treatment

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