Teva announced that the U.S. Food and Drug Administration (FDA) approved two products for adolescent and adult patients with asthma. These products, AirDuo RespiClick (fluticasone propionate and salmeterol inhalation powder) and ArmonAir RespiClick (fluticasone propionate inhalation powder), include medication delivered via Teva’s RespiClick breath-activated, multi-dose dry powder inhaler (MDPI) which is used with other approved medicines in Teva’s respiratory product portfolio.
AirDuo RespiClick is a fixed dose combination product containing the same active ingredients as Advair. AirDuo RespiClick is a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) indicated for the treatment of asthma in patients aged 12 years and older. ArmonAir RespiClick is an inhaled corticosteroid (ICS) containing the same active ingredient as Flovent, and is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 12 years and older.
“As a company on the forefront of developing inhaler technologies for people living with asthma, we are very pleased to now have two additional RespiClick®-delivered medicines approved for adolescent and adult patients in the U.S.,” said Michael Hayden, MD, PhD, President of Global R&D and Chief Scientific Officer at Teva. “The expansion of our breath-activated product portfolio underscores Teva’s commitment to developing medicines that truly meet the needs of patients living with asthma and other respiratory diseases.”
Rob Koremans, M.D., President and CEO of Global Specialty Medicines at Teva said, “With these approvals, we now integrate both fixed dose combination and monotherapy into our core, breath-activated RespiClick device. 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.”
AirDuo RespiClick and ArmonAir RespiClick are expected to become available to patients in the U.S., by prescription, later this year. Both products have been approved in three strengths. The approved strengths of AirDuo RespiClick are: 55/14 mcg, 113/14 mcg and 232/14 mcg administered as one inhalation twice daily. The approved strengths of ArmonAir RespiClick are: 55 mcg, 113 mcg, and 232 mcg administered as one inhalation twice daily.
“Prescribing the lowest effective dose of a medication is a key clinical objective in the treatment of asthma. It’s equally important that patients use their asthma inhalers correctly to ensure medicine is reaching the lungs,” said Dr. Lyndon Mansfield, MD, Clinical Professor of Pediatrics, Paul Foster School of Medicine, El Paso, TX. “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.”
The FDA’s approval of AirDuo RespiClick and ArmonAir RespiClick is supported by data from Teva’s clinical development program, including three Phase III trials which evaluated the efficacy and safety of the treatments in adolescent and adult patients with asthma. In the two double-blind studies, both therapies showed clinically relevant and greater benefit compared with placebo in the improvement of lung function after 12 weeks of treatment as measured by Forced Expiratory Volume in one second (FEV1). In clinical trials for AirDuo RespiClick, the most common adverse reactions (incidence ≥3%) were nasopharyngitis, headache, cough, oral candidiasis and back pain. In ArmonAir RespiClick clinical trials, the most common adverse reactions (incidence ≥3%) were nasopharyngitis, headache, cough, oral candidiasis and upper respiratory tract infection.
Filed Under: Drug Discovery
