Article preview reprinted from IN VIVO - October/November, 2009
The FDA's Anesthesiology and Respiratory Device Panel delivered good news to the interventional pulmonology sector by issuing a positive recommendation for Asthmatx Inc.'s Alair Bronchial Thermoplasty System, a treatment for severe asthma. The positive news came nearly a year after the same panel voted not to recommend Emphasys Inc.'s lung airway valve as a treatment for emphysema. Read more...
Asthmatx Positive Panel Outcome Good Sign for Pulmonology Companies
Article preview reprinted from IN VIVO - October/November, 2009
Asthmatx Inc. executives undoubtedly felt pressure going into last month's hearing with the Food and Drug Administration's Anesthesiology and Respiratory Therapy Devices Panel, from which it sought a positive recommendation for its Alair bronchial thermoplasty system. Everything is at stake at these meetings: years of work; millions of venture capital dollars; the hopes and aspirations of employees who've toiled to develop a device to make sick people better. But the six-year-old start-up brought even more than the usual baggage to Rockville, MD. A negative recommendation from the panel might have been a serious blow to the interventional pulmonology industry that's been long on promise but short on results. (See "Devices Fill the Lung Space," START-UP, January 2006.)
Nearly a year earlier, the same panel voted overwhelmingly, 13-2, to not recommend approval of Emphasys Medical's Zephyr bronchial valve, a treatment for emphysema that involved implanting a small one-way valve into the lung's passage in such a way as to replicate the effects of lung volume reduction surgery. The rejection ultimately shut down Emphasys, which couldn't afford the additional round of clinical trials sought by the FDA. (See "Emphasys on the Block after FDA Panel Rejection," START-UP, February 2009. Pulmonx Inc., another pulmonary start-up, acquired Emphasys. Terms of the deal weren't disclosed. It's difficult to say exactly how venture investors might have reacted to a negative vote on Asthmatx's Alair. The company presents a different approach and targets a different condition, but investors already are wary of the FDA and could have interpreted another negative vote as a knock against the entire interventional pulmonary field.
Fortunately, the bad news never came. The FDA panel voted 6-1 to recommend that the agency approve the Asthmatx treatment for drug-resistant asthma. The agency typically follows the recommendations of its advisory panels. The outcome speaks well to Alair's ability to reduce attacks and complications for people suffering from severe asthma. Asthmatx believes the device could be an option for two to three million people—between 10% and 15% of the 22 million asthmatics—who have asthma so severe it doesn't respond to drug-based treatment. (See "Asthmatx Breathes Easier," IN VIVO, October 2007.)
Asthmatx made the most of its second-mover advantage. President and CEO Glen French says he watched Emphasys' experience over time and also talked with his counterparts at other device companies that recently went before an advisory panel. "We absolutely were informed by the Emphasys experience as well as the experiences of a number of other companies that went before the panel," French says.
Asthmatx thus took a different approach to the design of its pivotal clinical trial. Asthmatx incorporated sham elements into its clinical trial, as did interventional pulmonology companies Broncus Technologies Inc. and Spiration Inc., a tactic that might bode well for future reviews of interventional pulmonology companies. (Broncus expects to begin analyzing data from its study this quarter, with a PMA filing expected in 2010. Spiration is still enrolling patients in its 500-patient trial.) Emphasys, instead, compared the population of clinical trial participants who had received the Zephyr with those who underwent standard medical treatment. Patients knew whether they were receiving the experimental treatment or not.
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Companies mentioned in this article:
Asthmatx Inc.
Broncus Technologies Inc.
Olympus Corp.
Olympus Medical Systems Corp.
Pulmonx Inc.
Emphasys Medical Inc.
Spiration Inc.
University of Miami
University of Washington
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