Please login to the form below

Not currently logged in
Email:
Password:

Amicus Therapeutics launches Fabry treatment Galafold in Italy

Follows publication of Ministry of Health's reimbursement guidelines

Amicus TherapeuticsUS biotech Amicus Therapeutics has launched its new Fabry disease treatment Galafold (migalastat) in Italy after winning reimbursement coverage.

Final reimbursement guidelines from the Ministry of Health back Galafold for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation.

John Crowley, Amicus chairman and CEO, said: "The commercial launch of Galafold in Italy is a significant milestone for the Fabry community.

“We believe that our successful pricing and reimbursement in Italy is a testament to the significant value of our oral precision medicine, and reflects our growing momentum with the country-by-country processes to launch Galafold throughout the EU.”

Galafold is the first orally administered alternative to the current crop of injectable enzyme replacement therapies (ERT) for Fabry disease, such as Sanofi's Fabrazyme (agalsidase beta).

Amicus’ therapy is a first-in-class chaperone therapy and works by stabilising the body's own dysfunctional enzyme.

Galafold received NICE backing for England and Wales last month and has been recommended as a treatment option in the US, on condition that Amicus provide it at a discounted rate.

Article by
Dominic Tyer

14th March 2017

From: Sales

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Oncosec

OncoSec is a clinical-stage biotechnology company focused on developing cytokine-based intratumoral immunotherapies to stimulate the body's immune system to target...

Latest intelligence

How do companies prepare for reimbursement?
Valid Insight explore how to optimise your market access strategy during new product development, how to address payer concerns and prepare for reimbursement....
EHR clinical trials
Integrating electronic health records into clinical trials
How organisations are working to realise the research potential of EHRs...
Mike Elliott Gilead
Keeping up the fight against HIV and using the lessons to tackle other threats
Danny Buckland interviews Gilead’s Mike Elliott...

Infographics