FDA Expands Approval of SPIRIVA® RESPIMAT®

  • FDA Expands Approval of SPIRIVA® RESPIMAT®, Steroid-free Respimat now approved as asthma treatment for age 6 and older
  • Supplemental New Drug Application (sNDA) approved under priority review from the FDA
  • FDA also granted pediatric exclusivity to SPIRIVA

Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved SPIRIVA RESPIMAT for the long-term, once-daily maintenance treatment of asthma in people age 6 and older. SPIRIVA RESPIMAT is not a treatment for sudden asthma symptoms.

The FDA approved the Supplemental New Drug Application (sNDA) under a priority review designation, and the FDA also granted pediatric exclusivity to SPIRIVA RESPIMAT in light of the clinical trials conducted by Boehringer Ingelheim.

SPIRIVA RESPIMAT is steroid-free and works differently from other treatment options to open airways to help people breathe better. In its comprehensive clinical trial program, SPIRIVA RESPIMAT demonstrated proven efficacy and safety for patients age 6 and older.

“It is important for healthcare providers to identify and treat patients who may be taking a controller medicine, but who continue to experience uncontrolled asthma symptoms that can make it difficult to breathe and may even cause an exacerbation,” said Bradley E. Chipps, MD, Capital Allergy & Respiratory Disease Center, Sacramento, California. “As healthcare providers, we need options, like SPIRIVA RESPIMAT, to consider as an add-on treatment to improve asthma symptoms for the broad age range of patients who may need more control.”

SPIRIVA RESPIMAT, which is delivered as 2 puffs once a day of 1.25 mcg per puff, is part of a class of medicines called long-acting muscarinic antagonist (LAMA) and is the only one of its kind approved for asthma. SPIRIVA RESPIMAT was approved in September 2015 for the long-term, once-daily, prescription maintenance treatment of asthma in people age 12 and older. In the treatment of asthma, the maximum benefits in breathing may take up to 4 to 8 weeks.

Asthma is a chronic respiratory disease that can cause airways to become narrower and irritated, making it difficult to breathe. It currently affects nearly 6.3 million American children. Asthma symptoms can be serious, and uncontrolled asthma could lead to emergency room visits, hospital stays and missed days of school.

“This FDA approval expands the indication of SPIRIVA RESPIMAT to a broad range of people, including children, adolescents and adults who may be experiencing uncontrolled asthma,” said Sabine Luik MD, Senior Vice President, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “For nearly a century, Boehringer Ingelheim has been focused on addressing serious unmet needs. This approval is further evidence of our ongoing commitment to improving the lives of the patients we serve.”

This FDA approval is based on efficacy and safety data from the Phase II and Phase III UniTinA-asthma® clinical development program, which included more than 150 sites globally with over 6,000 patients, including 804 children (aged 6-11 years).

About Asthma

More than 24 million people in the U.S. have asthma, including 6.3 million children under the age of 18. Asthma is a chronic disease and despite taking maintenance treatments, many children and adults continue to have uncontrolled asthma. According to the CDC, 50 percent of adults and over 38 percent of children with asthma in the U.S. remain symptomatic, despite maintenance treatment.

When a person with asthma comes into contact with an asthma trigger (e.g., infections, pollen, and smoke), their airways can become inflamed, swollen and constricted and excess mucus is produced. These reactions can cause the airways to become narrower and irritated, making it difficult to breathe. People suffering from asthma experience recurrent episodes of wheezing, breathlessness, chest tightness and coughing. Asthma attacks occur when symptoms become more intense or frequent.

About the RESPIMAT Inhaler

RESPIMAT, the platform inhaler for the Boehringer Ingelheim respiratory therapies, was designed to get medicine deep into patients’ lungs as a slow-moving mist. The slow moving mist of the RESPIMAT inhaler provides patients with enough time to breathe in the medication. The RESPIMAT inhaler operates independent of inspiratory effort, helping patients effectively breathe the medicine into their lungs while minimizing inhalation effort.

As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as coordination between actuation of the inhaler and inspiration through the delivery system. The duration of inhalation should be at least as long as the spray duration (1.5 seconds).

Boehringer Ingelheim’s RESPIMAT family of products includes five FDA-approved medicines for COPD and asthma.