Teva Pharmaceuticals (NYSE:TEVA) said today that the FDA approved 2 inhaled asthma medications to be delivered using the company’s RespiClick breath-activated, multi-dose dry powder inhaler. The products, AirDuo RespiClick and ArmonAir RespiClick, are indicated for use in asthma patients as young as 12 years old.
The Jerusalem-based company’s AirDuo RespiClick is a fixed dose combination of a corticosteroid and a long-acting beta-adrenergic agonist, while the ArmonAir RespiClick is an inhaled corticosteroid.
“As a company on the forefront of developing inhaler technologies for people living with asthma, we are very pleased to now have 2 additional RespiClick-delivered medicines approved for adolescent and adult patients in the U.S.,” chief scientific officer & president of global R&D Dr. Michael Hayden said in prepared remarks. “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.”
“With these approvals, we now integrate both fixed dose combination and monotherapy into our core, breath-activated RespiClick device,” president & CEO of global specialty medicines Dr. Rob Koremans added. “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 company said it expects that its 2 products, which have been approved in 3 strengths, will become available to patients in the U.S., by prescription, later this year.
“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,” Dr. Lyndon Mansfield, clinical professor of pediatrics at the Paul Foster School of Medicine, said. “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 federal watchdog’s approval was supported by clinical data from 3 phase III trials, proving the efficacy and safety of the products in adolescent and adult asthma patients. In 2 double-blind studies, both AirDuo and ArmonAir demonstrated clinically relevant improvement in lung function after 12 weeks of treatment compared to a placebo. The most common adverse reactions were nasopharyngitis, headache, and cough.
Last month, the company said it would pay $519 million to settle allegations that the company bribed overseas officials in Mexico, Russia and Ukraine to promote its products, according to the U.S. Justice Dept. The department reported that the millions of dollars in bribes occurred for more than a decade.
The pharmaceutical giant agreed to $238 million to settle Foreign Corrupt Practices Act allegations, as well as $236 million in profits plus interest to resolve the Securities and Exchange Commission’s civil investigation.