The European Commission has granted marketing authorization to Pharmaxis for its Bronchitol mannitol inhalation powder for the treatment of cystic fibrosis in patients 18 and over. In October 2011, the CHMP adopted a positive opinion regarding approval of the drug after several prior negative opinions.
The company will officially launch the product in Europe at the European Cystic Fibrosis Symposium, which begins on June 6; however, CF patients in the UK and Germany should have access to the product by mid-May. Once Pharmaxis has pricing and reimbursement approval from the remaining countries, Bronchitol should be available in 29 countries for about €20-25 per day, the company says.
Pharmaxis CEO Alan Robertson commented, “This is a very significant event, which means that patients living with cystic fibrosis in Europe will now be able to receive the proven clinical benefits of Bronchitol. We have built considerable momentum around Bronchitol in recent months with the German and UK sales teams fully recruited. The CF centers have been introduced to Pharmaxis and information on local treatment practices has been collected.”
“Pharmaxis has now secured three drug approvals in the world’s largest pharmaceutical markets,” Robertson continued. “This is a credit not only to the company but also the investigators and patients throughout the world who have taken part in our clinical programs.”
Read the Pharmaxis press release.
