Asthma: U.S. FDA approves new indication for SPIRIVA Respimat

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The FINANCIAL — Boehringer Ingelheim on September 16 announced that the U.S. Food and Drug Administration (FDA) approved SPIRIVA Respimat (tiotropium bromide) Inhalation Spray for use in the treatment of asthma. It is approved by the FDA for the long-term, once-daily, maintenance treatment of asthma in patients 12 years of age and older.

Following previous regulatory approvals, tiotropium by soft-mist inhaler has been included in the recently updated Global Initiative for Asthma report (GINA) 2015 Global Strategy for Asthma Management and Prevention, according to Boehringer Ingelheim.

Almost one in two patients with asthma still experience symptoms while receiving maintenance therapy putting them at increased risk of potentially life-threatening asthma exacerbations. Pivotal, Phase III study results show that Spiriva Respimat as an add-on treatment to ICS/LABA maintenance therapy:

Significantly improves asthma symptoms 

patients are 68% more likely to improve asthma control

Significantly reduces the risk of patients having a severe asthma exacerbation by a fifth (21%)

reducing the number of patients who experienced a severe asthma exacerbation8

The Phase III study results also showed that the safety of SPIRIVA Respimat is balanced as compared to placebo.

Since 2014, SPIRIVA Respimat has been approved for use in asthma in over 50 countries, including in the EU and Japan.

“The U.S. FDA approval of SPIRIVA Respimat in asthma establishes a new class of inhaled asthma therapy and provides an efficacious, new option for patients. There is extensive clinical evidence demonstrating that SPIRIVA Respimat can improve outcomes for patients with asthma who remain symptomatic despite the use of ICS/LABA maintenance therapy. This is reflected by the inclusion of SPIRIVA Respimat in the latest update of the GINA global asthma management strategy,” said Dr William Mezzanotte, Head of Respiratory Medicine, Boehringer Ingelheim.

 

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