(Italy). The first treatment (Skyclarys) for Friedreich's ataxia will be reimbursed by the National Health Service

At its meeting on 15 December, the AIFA Board of Directors gave the green light to the reimbursement of Skyclarys (omaveloxolone), an orphan drug for the treatment of Friedreich's ataxia.

Skyclarys, the first medicine proven to slow the progression of the disease, was authorised by the European Medicines Agency (EMA) in February 2024 and included by AIFA in July 2024 in the list of medicines distributed under Law No. 648/1996, an early access programme that allows free dispensing to eligible patients, with the cost entirely covered by the National Health Service. Now, following negotiations with the marketing authorisation holder, the medicine will be available for reimbursement for the treatment of patients aged 16 years and older, upon prescription by centres for the treatment of rare diseases.