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November 14, 2013

Boehringer seeks European approval for expanded indication of tiotropium Respimat

German pharmaceutical firm Boehringer Ingelheim has submitted European marketing authorisation (MA) applications to extend the indication to use tiotropium (Spiriva) Respimat for the treatment of asthma in adults aged 18 years and over.

By admin-demo

German pharmaceutical firm Boehringer Ingelheim has submitted European marketing authorisation (MA) applications to extend the indication to use tiotropium (Spiriva) Respimat for the treatment of asthma in adults aged 18 years and older.

The MA applications are based on results from the UniTinA-asthma Phase III clinical trial programme, which involves more than 4,000 patients in over 150 sites worldwide.

The programme is aimed at assessing the efficacy and safety of tiotropium Respimat in patients with asthma.

Boehringer Ingelheim corporate senior vice-president Medicine Klaus Dugi said the company’s extensive studies have showed that tiotropium Respimat has the potential to be an effective new treatment option that can provide benefits and improve outcomes for adult patients with asthma.

"We look forward to results from the paediatric UniTinA-asthma Phase III studies, which are anticipated to become available in 2014," Dugi said.

"At least 40% of patients with asthma remain symptomatic and may experience frightening and life-threatening asthma exacerbations, despite using the available therapeutic options, and we believe that tiotropium, once approved, can help address this clear unmet medical need."

"At least 40% of patients with asthma remain symptomatic and may experience frightening and life-threatening asthma exacerbations, despite using the available therapeutic options, and we believe that tiotropium, once approved, can help address this clear unmet medical need."

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The clinical trial programme includes a total of 11 Phase III studies investigating tiotropium Respimat added to standard treatment in adults, adolescents and children (aged one-year or older) with persistent asthma across the spectrum of severity.

The first data to come from the programme were the PrimoTinA-asthma studies, which showed the efficacy and safety of tiotropium in asthma patients who remained symptomatic despite treatment with at least ICS/LABA therapy.

Data from the PrimoTinA-asthma studies showed that the addition of tiotropium Respimat increased the time to first severe asthma attack and also the first episode of asthma worsening compared with placebo.

The data secured from the MezzoTinA-asthma Phase III twin studies were also included in the MA applications for tiotropium Respimat in asthma.

The twin studies demonstrated that in asthma patients who remain symptomatic despite moderate-dose maintenance ICS therapy, the addition of tiotropium Respimat improves lung function, offers sustained bronchodilation over 24 hours and provides a statistically significant and clinically relevant improvement in asthma control.

Tiotropium is a long-acting inhaled anticholinergic bronchodilator that is being jointly developed by Boehringer Ingelheim and Pfizer under an asthma clinical development programme.

Under the terms of the partnership, Boehringer Ingelheim will manage operations for all clinical development activities but the product will be commercialised by both companies.

Tiotropium is already approved for the treatment of chronic obstructive pulmonary disease, but not for asthma since its safety and efficacy have not yet been fully established.

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