FDA Agrees To Review Spiriva Respimat By Boehringer Ingelheim To Treat Asthma

FDA Agrees To Review Spiriva Respimat By Boehringer Ingelheim To Treat Asthma

The Food and Drug Administration (FDA) recently agreed to review a new drug application (NDA) by Boehringer Ingelheim for Spiriva Respimat (tiotropium bromide) Inhalation Spray to treat asthma.

Spiriva Respimat is an experimental therapy current being tested to treat asthma in patients who are 12 years of age and older, and Boehringer Ingelheim is studying tiotropium in asthma patients across a range of ages and disease severities. The UniTinA-asthma® program includes more than 6,000 adult, adolescent and pediatric asthma patients in more than 150 sites globally. The company notes that the drug is designed to be used for long-term treatment of asthma, once per day, by those who remain symptomatic even after the use of inhaled corticosteroids (ICS). ICS is the most common treatment for asthma although, in some cases, patients still experience symptoms and need another therapeutic alternative that can solve their unmet medical needs for controlling the disease.

Spiriva Respimat is a long-acting muscarinic antagonist (LAMA) that is being evaluated to assess if it is effective and safe to treat patients suffering with asthma, since it is not currently approved for this indication.

The drug is already approved to as a daily treatment for bronchospasm in chronic obstructive pulmonary disease (COPD), and to reduce exacerbations. 

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“Boehringer Ingelheim is committed to addressing the unmet medical needs of patients with a variety of respiratory conditions,” said Sabine Luik, Boehringer Ingelheim Pharmaceuticals senior vice-president of Medicine & Regulatory Affairs. “We look forward to further discussions with the FDA about the potential use of Spiriva Respimat in asthma.”

This NDA request is based on data from the large UniTinA-asthma® international Phase III clinical trial program, including ” the pivotal PrimoTinA- (NCT00772538/NCT00776984), MezzoTinA- (NCT01172808/NCT01172821) and RubaTinA-asthma (NCT01257230) studies,” cited in a reset company press release.

These trials assessed tiotropium being delivered via the Respimat inhaler and as an add-on treatment for adolescents and adults with moderate to severe asthma that were continuing to experience symptoms after treatments with ICS.

Boehringer Ingelheimfounded in 1885, targets multiple therapeutic areas such as cardiovascular disease, respiratory diseases, diseases of the central nervous system, metabolic diseases, virological diseases and oncology.

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