Amicus Therapeutics, Inc. (NASDAQ:FOLD) recently announced that National Institute for Health and Care Excellence (NICE) has provided its positive insight for GALAFOLD™ (MIGALASTAT), as a treatment for Fabry Disease, in England. The company stated that NICE’s Highly Specialised Technologies Evaluation Committee (EC)’s final evaluation determination (FED) has come with valuable insights.
NICE recommended commissioning Galafold in England for the purpose of National Health Service (NHS). It is important to note here that Galafold will be used within NHS as a first-line therapy treatment for adolescents aged 16 years and above, along with adults, for a longer duration.
This will be used as a treatment among patients where Fabry disease has been confirmed on diagnosis. This is an alpha-galactosidase A deficiency disease among people with amenable mutation. In the early months of this year, the company plans to bring the treatment in Northern Ireland, Wales and England.
First oral medicine for Fabry disease in the UK
The CEO and Chairman of company, John F. Crowley said that NICE’s positive FED is a significant step towards the patients suffering from Fabry in the UK. On being introduced in the markets there, Galafold will become the first oral medicine in the UK, for patients aged 16 years and above.
The evaluation process included Fabry patients themselves, advocacy groups and physician experts. The CEO stated that the company was moving faster now, in making available, Galafold, as a commercial medicine in the U.K.
The European Commission’s Approval
Earlier in May 2016, the medicine was given a full approval in the form of first line therapy for Fabry patients. The European Commission had agreed unanimously to approve the medicine for long-term treatment, among the aforesaid having amenable mutation.
The company’s collaboration with Fabry community is getting it commercial markets with 100% approvals. This new oral treatment will play a vital role in treating these patients.
This made 2017, an important year for company since the good news came right in the first week.