FDA approves QVAR RediHaler as maintenance therapy for asthma

Teva Pharmaceuticals announced that the FDA approved QVAR RediHaler inhalation aerosol for the prophylactic treatment of asthma in patients aged older than 4 years, according to a company press release.

Although the QVAR RediHaler contains the same active drug ingredient as the current form of QVAR (beclomethasone dipropionate HFA) inhalation aerosol, its mode of delivery incorporates a breath-actuated metered-dose inhaler (MDI), which eliminates the requirement for hand-breath coordination during inhalation.

“When working to manage asthma on a daily basis, proper administration of medication is of paramount importance,” Warner W. Carr, MD, associate medical director of Southern California Research at Allergy and Asthma Associates of Southern California Medical Group, said in a press release. “However, research has indicated that approximately 76% of patients still struggle to use their MDI inhalers correctly, 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.”

The FDA based its approval on data from one phase 1 and four phase 3 studies that evaluated the safety and efficacy of the QVAR RediHaler among patients with asthma aged 4 years and older. The most common adverse events associated with the use of QVAR RediHaler included oral candidiasis, upper respiratory tract infection, nasopharyngitis, allergic rhinitis, oropharyngeal pain and sinusitis.

“It’s important that we uncover new opportunities to take long-standing, clinically effective medications, such as QVAR, and incorporate them into device technologies that may help address key ongoing issues for patients, including inhaler technique,” Tushar Shah, MD, head of late-stage development at Teva Pharmaceuticals, said in the release. “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.”

Teva also noted that although the QVAR RediHaler is not indicated for the relief of acute bronchospasm, it has been designed to be used without shaking or priming, and therefore, should not be used with a spacer or volume holding chamber.