The U.S. Food and Drug Administration (FDA) has approved the dry inhalation powder Bronchitol (mannitol) as a maintenance treatment to be used along with other therapies for improving lung function in adults with cystic fibrosis (CF).
Bronchitol is currently approved and marketed in Switzerland, Australia, Italy, Russia, and several other countries. The therapy is expected to be launched in the U.S. market in March 2021, according to Chiesi USA, the exclusive distributor of Bronchitol in the U.S.
“Our teams have worked tirelessly toward today’s FDA approval, and we are thankful that we stayed the course to arrive at this moment,” Ken McBean, CEO of Chiesi USA, said in a press release.
“We’re thrilled to achieve this important milestone for the U.S. market and congratulate all Chiesi team members and partners who supported the clinical process,” he said.
Bronchitol’s active ingredient, mannitol, is a sugar alcohol that is able to attract water. When directed to the lungs, using a small dry powder inhaler device, mannitol draws water into the airways and moisturizes the mucus, making it easier for patients to expel the mucus.
By increasing mucus clearance, Bronchitol can help improve lung function and quality of life for people with CF. It’s the only inhaled dry powder indicated to be used along with other treatments to improve lung function in adults with CF.
“Bronchitol offers a portable and discreet option for CF management, with no routine cleaning or maintenance of the inhaler device required,” said Carmen Dell’Anna, MD, global medical excellence head at Chiesi.
“We are excited to achieve its approval in the U.S. for adults living with cystic fibrosis,” she added.
To date, a total of 761 adult CF patients have been enrolled to assess the safety and efficacy of Bronchitol in three Phase 3 studies (NCT00630812, NCT00446680, NCT02134353). Participants were randomly assigned to receive either Bronchitol or a placebo for 26 weeks, and entered an open-label treatment portion for an additional 26 weeks.
The main goal of these trials was to determine improvements in lung function, measured by change from baseline in forced expiratory volume in one second (FEV1), over 26 weeks. Other measures of lung function and pulmonary exacerbations, or respiratory infections leading to worsening of lung function, were also examined over time.
Overall, results showed a significant improvement in lung function in treated patients when compared with a placebo. The rates of pulmonary exacerbations also tended to be lower after Bronchitol treatment — though not significantly lower in all trials.
While one of these trials examined Bronchitol in patients 6 and older, the safety and efficacy of this treatment in children and adolescents is still not clear. Thus, the current indication for Bronchitol is for clinically stable adults only.
Before treatment initiation, however, patients are required to undergo a Bronchitol tolerance test. Here, healthcare providers give patients a first dose to evaluate if the treatment will cause bronchospasm (a sudden tightening in the walls of the airways) or a decrease in FEV1 and in oxygen blood levels. If any of these events occur, the treatment will not be prescribed.
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