According to Pharmaxis, Bronchitol, a new cystic fibrosis treatment, has been granted EU approval for patients aged 18 years and older as an add-on therapy to the best standard of care in 29 European countries.
Dr. Alan Robertson, CEO of Pharmaxis announced:
“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.”
The first to benefit from Bronchitol will be CF patients in Germany and the UK, where there is a lower requirement approving prices and reimbursement prior to the drug’s launch. Both countries make up 40% of the European market by value. According to Pharmaxis, stock should be available for sale in Europe by June 1st ahead of the product’s official launch at the European Cystic Fibrosis Conference in Dublin (6th to 9th June 2012).
Bronchitol has been designed to help clear people’s airways who suffer from the world’s most common, life-limiting genetic disease – cystic fibrosis. Bronchitol demonstrated in two large Phase III clinical trials that it improved mucus clearance, improved lung function and decreased the number of infectious episodes in comparison to controls after 6 months of therapy. Dr Robertson declared:
“We have built considerable momentum around Bronchitol in recent months with the German and UK sales teams fully recruited and trained. Pharmaxis has now secured three drug approvals in the world’s largest pharmaceutical markets: the lung function test Aridol in Europe and the US and now approval for Bronchitol in Europe and Australia. 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.”
Written By Petra Rattue