FDA expands indication for asthma rescue inhaler to younger patients

Teva Pharmaceuticals announced today that the FDA has expanded the indication for its ProAir, RespiClick inhalation powder to include patients with asthma aged 4 to 11 years, according to a press release.

Last year, the FDA approved the rescue inhaler and inhalation powder (albuterol sulfate) only for patients aged 12 years and older to treat or prevent bronchospasm.

“The prevalence of childhood asthma in the U.S. is high, at more than 6 million patients, and that number continues to rise,” Erwin W. Gelfand, MD, chairman, department of pediatrics at National Jewish Health, said in the release. “For this young population of asthma patients, learning to use inhalers properly can be quite challenging. Thus, the pediatric indication of ProAir RespiClick is important as it represents a new rescue inhaler option for younger patients that eliminates the need for hand-breath coordination during inhalation and was designed to be used without a spacer.”

The rescue inhaler is the only breath-actuated, multidose, dry-powder, short-acting-beta-agonist device available domestically, the release said.

Previously, the FDA reviewed data from Teva’s phase 3 trial that evaluated ProAir RespiClick in patients with asthma who were aged as young as 4 years. The agency found that it significantly improved patients’ forced expiratory volume in 1 second, the release said. Adverse effects associated with the device included upper respiratory infections, mouth and throat pain and vomiting.

“We are very pleased with the FDA’s decision to expand the indication of ProAir RespiClick,” Tushar Shah, MD, senior vice president at Teva Global Respiratory Research and Development, said in the release. “The availability of this treatment option for younger patients is a demonstration of Teva’s commitment to optimizing respiratory therapies through the development of new delivery systems that help address needs in the marketplace.”