Bronchitol, an add-on therapy for adult cystic fibrosis (CF) patients, has cleared a major hurdle on its path to use in Europe. The pharmaceutical company Pharmaxis announced this week that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that bronchitol be granted a marketing authorization.
Pharmaxis now expects the European Commission to confirm this opinion and grant the marketing authorization for bronchitol in the 27 European Union member countries in January 2012.
“Life expectancy in cystic fibrosis is improving but there remains an urgent need for new therapies which can improve lung function and reduce exacerbations,” said Stuart Elborn, president of the European Cystic Fibrosis Society. “Bronchitol increases mucolciliary clearance and will be the first approved therapy in Europe with this mechanism of action and has been shown to improve both lung function and reduce exacerbations when added to standard medications in use today. I welcome this decision by the CHMP.”
Elborn’s American counterpart, Robert J. Beall, PhD, president and CEO of the American Cystic Fibrosis Foundation, also welcomes bronchitol’s European progress. “The Cystic Fibrosis Foundation is delighted to see an important new CF medicine being made available to patients in Europe. It takes a lot of dedication from industry and the CF community to develop a drug to this point. We are proud to have played a part in this process through our clinical trial group and look forward to Bronchitol being submitted to the FDA early next year.”
Bronchitol is for use in CF patients aged 18 and up. Pharmaxis plans to undertake a short-term clinical trial in children (age 6 to 17) with a view to extending the license to this age group.
Discovered and developed in Australia, bronchitol is already approved for marketing in Australia. Bronchitol’s approval for the treatment of CF patients in Australia and the European Marketing Application are based on the results of two Phase 3 clinical trials involving more than 600 people and conducted in 95 centers throughout the world.