NICE approves Bronchitol inhalation powder for CF

Pharmaxis’s Bronchitol mannitol dry powder for inhalation has become the first treatment for cystic fibrosis to receive a positive recommendation from he UK National Institute for Health and Clinical Excellence (NICE), according to the company. The recommendation allows for reimbursement by the National Health Service.

Pharmaxis CEO Alan Robertson commented, “Pharmaxis welcomes this decision from NICE, which recognizes Bronchitol as a clinically and cost effective treatment option for CF patients with the most unmet medical need. We have worked with clinicians and patient organisations to respond to questions from NICE during this review process and will continue to work alongside NICE and the CF community to ensure all eligible patients under Bronchitol’s licence can benefit from the drug.”

The Cystic Fibrosis Trust’s Director of Clinical Care Jo Osmond added, “We are very pleased with this decision from NICE, as we firmly believe that Bronchitol is an important addition to CF care, which will help to relieve the burden of treatment for adults with this debilitating condition.”

Pharmaxis submitted an NDA for Bronchitol in the US in June 2012. The product is already approved in the EU and Australia.

Read the Pharmaxis press release.

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