The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a Promising Innovative Medicine (PIM) designation for cenobamate, Arvelle Therapeutics’ investigational anti-seizure medication, 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).
Launched in 2014, EAMS aims to provide patients in the UK with life threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation when there is a clear unmet medical need.
“The MHRA PIM designation marks an important milestone for Arvelle,” said Stuart Mulheron, General Manager UK & Ireland, Arvelle Therapeutics.
“Together with the European Medicines Agency’s recent acceptance of the Marketing Authorisation Application and the FDA’s approval of cenobamate in the US, it further supports the potential of cenobamate as an innovative treatment approach for the estimated 1.6 million people with epilepsy in Europe who are still experiencing seizures despite taking anti-seizure medications.”