Pharmaxis has submitted an NDA for Bronchitol inhaled dry powder mannitol for the treatment of cystic fibrosis to the FDA.
Pharmaxis CEO Dr Alan Robertson said, “The submission marks the second of two key milestones for the Bronchitol program following approval last month to market the product in Europe. Cystic fibrosis patients have a life‐limiting disease. It starts at birth because of genetic mutations that impair the airway surface liquid lining of the lung leading to irreversible damage to the lung structure. Currently approved therapies for the majority of cystic fibrosis patients work on thinning mucus secretions, or on targeting the bacteria that infect the lung. Bronchitol targets restoration of the airway surface liquid and, by improving mucociliary clearance, positively impacts the cascade of events that otherwise lead to lung function loss.”
In Europe, the UK National Institute for Health and Clinical Excellence (NICE) has released a draft opinion stating that it would not consider Bronchitol a cost-effective use of NHS resources at this time, Pharmaxis has announced. According to the company, the recommendation could change before issuance of a final guidance.
Pharmaxis also announced pricing for Bronchitol in the UK and Germany. In the UK, where the pricing has been approved and the product has launched, the retail price is £16.55 a day. In Germany, the retail price will be €35.65 a day.
Read the Pharmaxis press release on the NDA.
Read the Pharmaxis press release on European commercialization.
