FDA approves two Teva asthma treatments

Dr. Michael Hayden Photo: Tamar Matsafi

Teva CSO Dr. Michael Hayden: The expansion of our breath-activated product portfolio underscores Teva’s commitment to patients with asthma.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) today announced that the US Food and Drug Administration (FDA) has approved two treatments for adolescents and adults with asthma. These treatments, 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.

Teva president Global R&D and CSO Dr. Michael Hayden said, “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 US. 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.”

Teva president and CEO of Global Specialty Medicines Dr. Rob Koremans 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 US, by prescription, later this year.

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.

Published by Globes [online], Israel business news - www.globes-online.com - on January 30, 2017

© Copyright of Globes Publisher Itonut (1983) Ltd. 2017

Dr. Michael Hayden Photo: Tamar Matsafi
Dr. Michael Hayden Photo: Tamar Matsafi
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