Pharmaxis' Bronchitol to get Scottish NHS listing
Pharmaxis (ASX:PXS) revealed its Bronchitol product has been approved for use by the National Health Service in Scotland for cystic fibrosis (CF) treatments.
The Scottish Medicines Consortium (SMC) has accepted Bronchitol for use by the NHS, marking the first time the agency has approved a non-antibiotic therapy for CF.
Bronchitol has marketing approval in Europe for the treatment of adult CF patients as an add-on therapy to standard-of-care treatments.
The SMC has now accepted Bronchitol’s use in Scotland in adults who are not currently using dornase alfa due to a lack of response, intolerance or ineligibility and have rapidly declining lung function.
“We are very pleased with this decision from SMC as we firmly believe that Bronchitol is an important addition to cystic fibrosis care,” Pharmaxis CEO Gary Phillips said.
In October last year, the UK’s National Institute for Health and Clinical Excellence (NICE) gave a positive recommendation to make Bronchitol available on the NHS in the UK.
But this January, the US FDA rejected a Pharmaxis New Drug Application for Bronchitol, citing inadequacies in the efficacy data provided for the application.
Pharmaxis (ASX:PXS) shares were trading 12% lower at $0.11 as of around 1.30 pm on Wednesday.
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