The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) Pharmaxis has adopted a positive opinion recommending the approval of a marketing authorization for Bronchitol inhaled dry powder mannitol formulation “for the treatment of cystic fibrosis in adults as an add‐on therapy to best standard of care,” says Pharmaxis. Patients with CF who are 18 and over, who currently represent about two thirds of the patients who could benefit, according to the company, will be able to use the drug. Pharmaxis anticipates that the MA will be granted by the EC in January 2012. The CHMP had previously issued several negative opinions on Bronchitol, as recently as June 2011.
“This outcome from the CHMP meeting is an important milestone for the company. It is good news for the cystic fibrosis (CF) community which has supported us throughout the development of Bronchitol,” commented Pharmaxis CEO Dr Alan Robertson. He added: “Pharmaxis will move quickly to commercialise Bronchitol in Europe. We have established our supply and logistics arrangements and advanced launch preparations and pricing applications with our marketing partner, Quintiles. The awareness of Bronchitol’s clinical data amongst CF clinicians has increased through publications and presentations at scientific conferences. European clinicians provided valuable support to the CHMP decision and are looking forward to Pharmaxis bringing this new therapeutic treatment option to their patients in the near future.”
European Cystic Fibrosis Society President Stuart Elborn noted, “Life expectancy in cystic fibrosis is improving but there remains an urgent need for new therapies which can improve lung function and reduce exacerbations. Bronchitol increases mucociliary 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.”
Robert J. Beall, President and CEO of the American Cystic Fibrosis Foundation added, “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 currently approved in Australia, and an EC approval would add 27 countries where the DPI will be available. Pharmaxis also said that it plans to initiate a clinical trial in children ages 6-17 to gather data to support a possible extension of the European license. The company is also developing Bronchitol for the treatment of bronchiectasis.
Read the Pharmaxis press release.
