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

Teva
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.”

FREE DAILY NEWSLETTER

Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

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.

Suggested Articles

The respiratory care company Vyaire Medical has brought on a new CEO, Gaurav Agarwal, following a year of new product launches.

Precision oncology firm Notable Labs is launching its first self-sponsored clinical trial, designed from the ground up to help validate its platform.

Inotrem and Roche’s diagnostics division have upgraded their years-long collaboration on a plasma test for septic shock, with a new worldwide deal.