MHRA approves first UK treatment for Friedreich’s ataxia

24 April 2025

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Skyclarys (omaveloxolone), the first treatment for patients aged 16 and over, in the UK for a rare neurodegenerative movement disorder called Friedreich’s ataxia (FA).

The new marketing authorization was granted to the Dutch subsidiary of US biotech major Biogen (Nasdaq: BIIB), which gained rights to the drug along with its $7.3 billion acquisition of Reata Pharmaceuticals last year.

According to the MHRA, Friedreich’s ataxia is the most common type of hereditary ataxia (caused by genes a person has inherited). It is thought to affect at least 1 in every 50,000 people. Symptoms of Friedreich’s ataxia include problems with balance and movement, which get progressively worse over time.

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