FDA OKs two more of Teva’s breath-activated inhalers

The FDA approved two breath-activated RespiClick products for the treatment of asthma, which join the ProAir RespliClick, a rescue inhaler.

The FDA approved two more inhalers in Teva’s breath-activated RespiClick line for adolescents and adults with asthma.

The AirDuo RespiClick is indicated for the treatment of asthma in patients aged 12 and up and contains the same ingredients as GlaxoSmithKline’s aging COPD treatment, Advair. The ArmonAir RespiClick, which has the same active ingredient as GSK’s Flovent, is indicated as a maintenance treatment of asthma in the same patient group.

“With these approvals, we now integrate both fixed dose combination and monotherapy into our core, breath-activated RespiClick device,” Dr. Rob Koremans, president and CEO of Global Specialty Medicines at Teva, said in a statement. “By expanding our RespiClick portfolio of breath-activated inhalers, we will provide physicians and their patients with additional treatment options in an inhaler device that does not require hand-breath coordination during inhalation.”

The FDA nod comes on the back of three phase 3 trials that assessed the safety and efficacy of the treatments in adolescent and adult asthma patients. Two double-blind studies showed both treatments outperformed placebo in improving lung function after 12 weeks of therapy.

The newly approved inhalers will hit the market later this year, according to the statement. Each therapy has been approved in three dosage strengths. Both treatments are administered as one inhalation twice a day.

“With research indicating that a significant number of patients still do not properly use their metered-dose inhalers, I am pleased that more asthma treatments and strengths are now approved in a device that eliminates the need for hand-breath coordination during inhalation,” Dr. Lyndon Mansfield, a clinical professor of pediatrics at the Paul Foster School of Medicine, said in the statement.