Israel’s Teva Pharmaceutical Industries has won U.S. Food and Drug Administration (FDA) approval for its QVAR RediHaler breath-actuated inhaler for maintenance treatment of asthma as a prophylactic therapy in patients 4 years of age and older.
The company expects its prescription-only inhalation aerosol to be commercially available in 40 mcg and 80 mcg strengths to asthma patients by early 2018.
QVAR RediHaler contains the same active drug ingredient — beclomethasone dipropionate HFA — found in QVAR Inhalation Aerosol, with a different mode of delivery, and is designed to be used without shaking or priming.
In addition, QVAR RediHaler differs from conventional metered-dose inhalers (MDIs) by using a breath-activated device, eliminating the need for hand-breath coordination while activating the device. Hand-breath coordination has, in fact, made it more difficult for patients to effectively administer inhaled medication from traditional MDIs.
That, says Teva, can cause exacerbations and ineffective control of asthma and chronic obstructive pulmonary disease (COPD), potentially resulting in acute attacks that require emergency care.
“When working to manage asthma on a daily basis, proper administration of medication is of paramount importance,” Dr. Warner W. Carr, of Allergy and Asthma Associates of Southern California Medical Group in Mission Viejo, said in a press release.
“However, research indicates that about 76 percent of patients still struggle to use their MDI inhalers correctly, Carr added, thus placing them at increased risk for asthma exacerbations.
“From a clinical perspective, QVAR RediHaler is a much-needed treatment option for these patients who may be experiencing continued difficulty with hand-breath coordination,” he said.
The FDA originally approved the currently available QVAR MDI — with dose counter formulation — in 2014. But Teva will discontinue the product early next year upon its launch of QVAR RediHaler. Teva is now encouraging patients and caregivers to talk with their healthcare professionals about how the product transition may affect their current treatment plans.
“It’s important that we uncover new opportunities to take longstanding, clinically effective medications, such as QVAR, and incorporate them into device technologies that may help address key ongoing issues for patients, including inhaler technique,” said Dr. Tushar Shah, Teva’s head of late-stage development. “The FDA approval of QVAR RediHaler brings to market inhaler technology aimed at enabling patients to more accurately administer the medication and ensuring they are receiving a proper dose with each inhalation.”
The Jerusalem-based conglomerate emphasizes that QVAR RediHaler Inhalation Aerosol should not be used for relief of acute bronchospasm.