The Committee for Medicinal Products for Human Use (CHMP) has recommended against granting a marketing authorization to Pharmaxis’s Bronchitol inhaled dry powder mannitol formulation for the treatment of cystic fibrosis. The CHMP had previously indicated that it would vote against the authorization. Pharmaxis chose not to withdraw the marketing authorization application.
Pharmaxis disagrees with the CHMP contention that there is insufficient evidence of the product’s effectiveness and says that the company “considers it has appropriate grounds upon which to request a re‐examination of the European Bronchitol marketing application.” The company must apply for a reexamination within 15 days.
According to Pharmaxis, several Phase 3 studies have demonstrated that Bronchitol helps to clear mucus in CF patients and improve lung function. CEO Alan Robertson says, “We remain committed to advancing Bronchitol for patients
affected by cystic fibrosis and will focus on addressing the concerns of the CHMP in the months ahead.
We have a clear understanding of the task in hand and are well advanced in our preparation.”
Read the Pharmaxis press release.
