FDA Recommends Approval Of Nondrug Asthma Treatment
An FDA panel on Wednesday voted to recommend approval for the first nondrug treatment for patients with asthma.
The Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee to the Food and Drug Administration voted 6 to 1 in favor to approve Asthmatx’s Alair System for adult patients with asthma that is uncontrolled by short and long acting medications.
The Alair System uses a bronchoscope, which is inserted through a patient’s nose or mouth into the lungs to send extreme heat to burn away lung tissue that makes it difficult to breathe.
The process, known as bronchial thermoplasty, and if approved, it would be the first nondrug treatment to gain FDA approval.
"Asthma is a serious public health problem. For many patients with severe asthma, even high doses of standard of care medications taken daily do not prevent frequent asthma attacks, which can be life-threatening," said Dr Mario Castro, Professor of Medicine at the Washington University School of Medicine, who presented data on the AIR2 Trial as the principal investigator.
Although asthma effects about 20 million people in the US, only about 2 million would qualify for the new treatment, Asthmatx said.
"We are hopeful that the FDA will concur with the recommendation made by the Panel today to make this procedure available to patients with severe asthma who have an enormous unmet medical need," Castro said.
The FDA traditionally follows the recommendations of its panels, although it is not required to.
"The Advisory Panel’s recommendation for approvable with conditions of the Alair System marks a major step in bringing this new and important treatment option to patients with severe asthma," said Glen French, CEO of Asthmatx.
"We look forward to working with FDA through the next steps to product approval."
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