The U.S. Food and Drug Administration (FDA) expanded the approval of steroid-free Spiriva Respimat (tiotropium bromide) for the maintenance treatment of asthma in children ages 6 and older.
The FDA approved the supplemental new drug application (sNDA) under priority review status due to the latest clinical trial results conducted by Boehringer Ingelheim, the drug’s manufacturer.
The Phase 3 trial program – CanoTinA-asthma (NCT01634139); VivaTinA-asthma (NCT01634152); RubaTinA-asthma (NCT01257230); and PensieTinA-asthma (NCT01277523) – demonstrated that Spiriva Respimat as a maintenance treatment for asthma significantly improved lung function and had a comparable safety profile to placebos. The treatment was also shown to improve peak expiratory flow (a person’s maximum speed of expiration; a measure of lung function).
“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,” Sabine Luik, MD, senior vice president of Boehringer Ingelheim, said in a press release.
The FDA approved first Spiriva Respimat in the U.S. in September 2015 to be used as a long-term, once-daily maintenance treatment for asthma patients age 12 and older.
The medicine is part of a class of drugs called long-acting muscarinic antagonists (LAMA) and the only one of its kind approved for asthma. Maximum benefits in breathing take from four to eight weeks of treatment.
Spiriva Respimat operates independently of inspiratory effort, but as with all inhaled drugs, the actual amount of drug delivered to the lungs may depend on patient factors, such as coordination between activating the inhaler and inspiration. Inspiration should last at least 1.5 seconds.
Spiriva Respimat is not meant for the treatment of sudden asthma symptoms (acute asthma). It is indicated for the long-term, once-daily maintenance treatment of the condition.
“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, from Capital Allergy & Respiratory Disease Center.
“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,” Chipps added.