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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