Privately-held Swiss CNS specialist Arvelle Therapeutics has been informed by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) that a Promising Innovative Medicine (PIM) designation has been issued for cenobamate for the treatment of drug-resistant focal-onset seizures in adults.
A PIM designation is an early indication that a medicinal product is a promising candidate for the Early Access to Medicines Scheme (EAMS), which aims to provide patients in the UK with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorization when there is a clear unmet medical need.
Stuart Mulheron, general manager UK & Ireland, Arvelle, said: “The MHRA PIM designation marks an important milestone for Arvelle.
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