MHRA designates cenobamate as a Promising Innovative Medicine for treating drug resistant seizures

pharmafile | August 13, 2020 | News story | Research and Development MHRA, cenobamate, seizures 

Arvelle Therapeutics has announced that the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has given their anti-seizure medication (cenobamate) a Promising Innovative Medicine (PIM) designation.

The drug was discovered by SK Biopharmaceuticals and SK life science and has been approved by the FDA to treat partial-onset seizures in adults. SK Biopharmaceuticals entered an exclusive licensing agreement with Arvelle to develop the treatment in Europe.

The drug has been studied in 2,500 people which includes 1,900 patients across two Phase 2 and one Phase 3 trials. In the double-blind placebo study, adult patients with drug-resistant focal onset seizures who were administered the drug as an adjunctive therapy have exceeded existing supportive care.  

The treatment works through enhancing inhibitory currents through positive modulation of GABA-A receptors at a non-benzodiazepine binding site, and decreasing excitatory currents by both inhibiting the persistent sodium current and enhancing the inactivated state of voltage-gated sodium channels.

The PIM designation means that the drug is a promising candidate for the Early Access to Medicines Scheme (EAMS). This scheme aims to give patients with life threatening or seriously debilitating conditions access to medicines that do not yet have market authorisation. This scheme also helps get treatments for those in medical need. The PIM is just step 1, with step 2 being an issue of a scientific benefit and risk option.

Stuart Mulheron, the General Manager of UK & Ireland, Arvelle Therapeutics, said: “The MHRA PIM designation marks an important milestone for Arvelle. Together, with the European Medicines Agency’s recent acceptance of the Marketing Authorization 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.”

Conor Kavanagh


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