FDA approves first device for severe, persistent asthma

July 15, 2010

The first non-drug treatment for severe asthma that is not well controlled by anti-inflammatory medicines won FDA approval April 27.

Key Points

The first non-drug treatment for severe asthma that is not well controlled by anti-inflammatory medicines won FDA approval April 27.

The device, dubbed the Alair System, is the brainchild and first product of privately held Asthmatx, a company in Sunnyvale, Calif. It uses a technology known as bronchial thermoplasty (BT) to deliver precisely controlled thermal energy to the lungs.

FDA approval of the Alair System was based on the results of the AIR2 Trial, a double-blind study that included 297 adult patients aged 18 and older who were considered to have severe, persistent asthma.

Two-thirds of the group were treated with BT while the others received a sham procedure that delivered no energy. Throughout the trial, all patients continued to take the cocktail of anti-inflammatory medications considered standard treatment.

Mario Castro, MD, principal trial investigator and professor of medicine and pediatrics at the Washington University School of Medicine, said that during the year-long study, BT brought about substantial improvements in his patients' quality of life.

Patients treated with the Alair device experienced a 32% reduction in asthma attacks; an 84% reduction in ER visits; a 73% reduction in hospitalizations; and a 66% reduction in days lost from work, school, or other daily activities as a result of respiratory distress.

In the days immediately following BT, there was an expected transient increase in the frequency and worsening of respiratory-related symptoms, Dr. Castro said. However, these events typically occurred within a day of the procedure and were resolved in approximately 7 days with anti-inflammatory medication.

The study was published in the January 15, 2010 issue of the American Journal of Respiratory and Critical Care Medicine.

Post-approval study

To continue monitoring the long-term safety and efficacy of BT, FDA is requiring Asthmatx to complete a 5-year post-approval study. Researchers will continue to follow patients who were enrolled in the initial study and 300 additional patients.

CEO French said that Asthmatx, a small company, does not yet have the sales force needed to respond immediately to the demand from all the doctors who want to try the procedure.

"All treating physicians require procedure training," French said. "For patients with severe asthma, this is a real advance, and we are working to add enough resources to help everybody."

Speaking of the company's financial situation, French told Drug Topics that Asthmatx had begun an "oversubscribed" initial public offering in 2006. However, the IPO was nixed after a Japanese medical company known as Olympus bought a $50 million stake in the company and persuaded Asthmatx to remain private. "The company is in a solid financial position, which allows it to consider a full array of strategic options," French said.

Lynn Shapiro is a freelance writer in New York City.