Boehringer Ingelheim COPD treatment gets FDA approval

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RIDGEFIELD, Conn. — Boehringer Ingelheim has received approval from the Food and Drug Administration for Stiolto Respimat Inhalation Spray, a medication for chronic obstructive pulmonary disease (COPD).

Stiolto is administered via Respimat, Boehringer Ingelheim’s inhaler that delivers a slow-moving mist to help patients inhale the medication.

The company said Tuesday that Stiolto Respimat Inhalation Spray (tiotropium bromide and olodaterol) was approved as a long-term, once-daily maintenance treatment for airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema.

“A recent review of landmark studies indicates that loss of lung function is more accelerated in the early stages of COPD. While no treatment slows the rate of decline, maintenance treatment with Stiolto Respimat initiated at the time of diagnosis will improve lung function,” stated Danny McBryan, vice president of clinical development and medical affairs, respiratory, at Boehringer Ingelheim Pharmaceuticals Inc.

Tiotropium is a long-acting anticholinergic maintenance therapy and the active ingredient in Spiriva Respimat Inhalation Spray (tiotropium bromide) and Spiriva HandiHaler (tiotropium bromide inhalation powder). Since its approval more than 10 years ago, Spiriva has extensive clinical experience, with over 40 million patient-years worldwide, and is the most prescribed COPD maintenance treatment in the United States and worldwide, according to Boehringer Ingelheim.

Olodaterol, approved for COPD patients as Striverdi Respimat Inhalation Spray, is a long-acting beta2-agonist maintenance treatment that improves airflow within five minutes after the first dose, the company said.

Stiolto is administered via Respimat, the platform inhaler for the Boehringer Ingelheim respiratory therapies, including approved and investigational therapies. Respimat is the only inhaler that actively delivers a slow-moving mist that helps patients inhale the medication, the company said, adding that the inhaler delivers medication independent of inspiratory effort. Stioloto Respimat does not replace the use of a rescue inhaler.

“Stiolto Respimat is a COPD maintenance treatment proven to be more effective than either Spiriva or olodaterol alone, with a comparable safety profile,” explained Sabine Luik, senior vice president of medicine and regulatory affairs at Boehringer Ingelheim Pharmaceuticals. “Patients may appreciate the benefits of a maintenance medication that improves lung function within five minutes, lasts all day and reduces the use of rescue inhalers.”


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