The US FDA has expanded the use of Spiriva Respimat for the long-term, once-daily maintenance treatment of asthma for pediatric patients age 6-11, which means the therapy is approved for use in people age 6 and older, according to Boehringer Ingelheim Pharmaceuticals Inc.
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.
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). The trial 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.
“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.”