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A leading asthma inhaler will now be available to additional younger asthma patients, after FDA approved Spiriva Respimat (Boehringer Ingelheim) for the long-term, once-daily maintenance treatment of asthma in people age 6 and older.
A leading asthma inhaler will now be available to additional younger asthma patients, after FDA approved Spiriva Respimat (Boehringer Ingelheim) for the long-term, once-daily maintenance treatment of asthma in people aged 6 years and older.
FDA approved the Supplemental New Drug Application (sNDA) under a priority review designation, and FDA also granted pediatric exclusivity to Spiriva Respimat in light of new clinical trials, which demonstrated proven efficacy and safety for patients aged 6 years and older. The inhaler was approved in September, 2015, for the long-term, once-daily, prescription maintenance treatment of asthma in people aged 12 years and older.
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The wholesale acquisition cost for Spiriva Respimat is $340.93 for a 30-day supply. “Formulary access for Spiriva Respimat is already favorable and widely covered by most major commercial and Medicare insurance plans,” Chris Wahlers, associate director of communications for Boehringer Ingelheim,” told FormularyWatch. “In addition, Boehringer Ingelheim offers a savings card that will allow most eligible patients to get Spiriva Respimat at no cost for 12 consecutive months, depending on their insurance provider.”
The steroid-free inhaler works differently from other treatment options to open airways to help people breathe better, according to a statement from Boehringer Ingelheim. Spiriva Respimat, delivered as 2 puffs once a day of 1.25 μg per puff, is part of a class of medicines called long-acting muscarinic antagonist (LAMA).
"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, with the Capital Allergy & Respiratory Disease Center, Sacramento, Calif. "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."
The new 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).