Alair BT System Approved By SFDA To Treat Severe Asthma
Espicom View : While device-based systems such as bronchial thermoplasty and renal denervation are currently used when pharmaceuticals have little to no effect, more and more such systems are being developed and may eventually be offered as alternatives to pharmaceutical therapies, thus making the latter redundant. The approval of Alair in China highlights the interest in these upcoming therapies, and with claims that asthma is rising in this region, China is an ideal target for the Alair system. The challenge will be increasing awareness and market penetration of Alair if Boston Scientific is to be successful.
Boston Scientific has received China State FDA (SFDA) approval for the Alair bronchial thermoplasty (BT) system, a medical device designed to treat severe asthma. The device is expected to be available in the Chinese market later in 2013.
Boston Scientific added the Alair system to its portfolio through the 2010 acquisition of Asthmatx, not long after the system received FDA clearance in the US. The Alair system provides an effective therapy for patients with severe asthma that is not well controlled with inhaled corticosteroids and long-acting beta agonists. Boston Scientific claims that 3-7% of adults with asthma have a severe form that is not well controlled. At device revenues of US$7,500 per patient, Boston Scientifc has stated that there is a US$20bn opportunity for BT, and with a 5% penetration per year, a potential annual market of US$1bn for Alair.
BT uses mild heat to reduce the excessive smooth muscle tissue in the airways. This reduces airway constriction during an asthma attack, making attacks less frequent and less severe. Unlike conventional treatments, BT offers a viable new option for patients suffering from severe asthma. BT delivered by the Alair system is an out-patient procedure performed in three sessions, typically scheduled three weeks apart.
BT delivered by the Alair system has been proven in clinical trials to be safe and effective. Data from Asthma Intervention Research 2 (AIR2), a multi-site, double-blind, sham-controlled study, demonstrated that after undergoing BT treatment, patients reported significant improvement in asthma-related quality of life. Furthermore, the benefit of a single BT treatment performed over three bronchoscopy sessions was shown to persist out to at least five years.
Key findings from the AIR2 trial reported at five years include:
• reduction in the percentage of BT-treated patients experiencing severe exacerbations (compared with patients treated with a sham control) was maintained out to five years;
• over five years, a 48% average decrease was observed in the rate of severe exacerbations in BT-treated patients compared with the year prior to receiving BT;
• over five years, an 88% average decrease was observed in the rate of emergency room visits for respiratory symptoms in BT-treated patients compared with the year prior to receiving BT;
• high resolution CT review showed no structural changes in the airways due to BT that were clinically significant; and
• no increase in hospitalisations, asthma symptoms or respiratory adverse events was recorded over five years.
Boston Scientific believes that the Alair system was the first device-based treatment approved by the FDA to treat asthma. This has enabled the company to enter a market that is currently dominated by pharmaceuticals. The approval in China allows Boston Scientific to expand the reach of this device, and propels the company towards reaching its revenues goals. Boston Scientific expects to increase Alair's FY2012 revenue of US$11mn to between US$20mn and US$30mn in FY13 and US$200mn in FY17. Boston Scientific has led the market with its Alair system since approval in 2010; however, there are companies, such as Sanovas, developing new systems that only require one treatment compared with three. We believe that Boston Scientific will have competition in this field in the near future.