For years, no new treatment has been available for asthma and COPD; now, in less than a week, novel therapeutic modalities for each have made progress with regulatory agencies.
On April 27, the U.S. Food and Drug Administration (FDA) approved the first medical device that uses radiofrequency energy to treat severe and persistent asthma in certain adults. The Alair Bronchial Thermoplasty System is intended for patients ages 18 and older whose severe and persistent asthma is not well-controlled with inhaled corticosteroids and long-acting beta agonist medications. “The approval of the Alair system provides adult patients suffering from severe and persistent asthma with an additional treatment option for a disease that is often difficult to manage,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health.
Bronchial thermoplasty is a bronchoscopic procedure in which controlled thermal energy is applied to the airway wall to decrease smooth muscle. In subjects with severe asthma, thermoplasty improved asthma-specific quality of life with a reduction in severe exacerbations and healthcare use in the 12-month post-treatment period. The FDA based its approval on data from a clinical trial of 297 patients with severe and persistent asthma. The FDA is requiring a five-year post-approval study of the device to determine its long-term safety and effectiveness.
On April 22, a positive opinion was given by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending the approval of roflumilast (Daxas®) for the maintenance treatment of severe chronic obstructive pulmonary disease (COPD) in the European Union. Roflumilast reduces the activity of phosphodiesterase 4 (PDE4), an enzyme important to the pathogenesis of COPD. Roflumilast is an anti-inflammatory agent targeting the systemic and pulmonary inflammation associated with COPD. This drug reduces inflammation in the lungs and narrowing of airways, and improves breathing problems in adults with severe COPD. The most common side effects are diarrhea, weight loss, nausea, stomach ache and headache. A post-marketing pharmacovigilance plan for roflumilast will be implemented.
In contrast, an FDA panel last month voted against approval for roflumilast on the grounds that the safety data is not convincing in light of a “modest” increase in lung function, as well as lack of comparative efficacy data. The pharmaceutical company that makes the drug, Forest, submitted an amended application requesting a more restrictive indication. The FDA is expected to make a final decision later this month.
These two treatments may not be devoid of side effects, but the benefit for patients with severe asthma or COPD appears to be of interest.