Epilepsy drug receives MHRA marketing authorisation

pharmafile | June 17, 2021 | News story | |  MHRA, epilepsy, marketing authorisation 

The MHRA has granted marketing authorisation (MA) for Ontozry (cenobamate) for the treatment of focal-onset seizures in adult patients with epilepsy, who have not been adequately controlled despite treatment with at least two anti-epileptic medicinal products.

The MA follows approval from the European Commission in March, via the reliance procedure, and will allow access to the treatment to eligible patients in England, Scotland, and Wales. In Northern Ireland, cenobamate is already approved for use following marketing authorisation received by the European Commission via the Centralised Procedure. Cenobamate is also already authorised in all EU Member States plus Iceland, Norway, and Liechtenstein.

The MA approval was based upon data from two trials, CO17 and CO21, which enrolled 1,784 patients. Results from the CO17 trial were published in The Lancet Neurology, and demonstrated a reduction in focal (partial)-onset seizure with patients receiving 100mg, 200mg, and 400mg of adjunctive cenobamate versus placebo.

Emmanuel Streel, Director of Medical Affairs, said: “Evidence from key clinical trials indicate that cenobamate can reduce the occurrence of focal-onset seizures which may lead to a potential new management option for adults with epilepsy who have not been successful in managing their condition with available therapies.

“Today’s decision by the MHRA means that an additional option to reducing the impact of adult epilepsy in Great Britain may now be possible.”

Focal onset seizures are an epileptic seizure that starts in one side of the brain. In the UK, it is estimated that 1 in 100 people have epilepsy and 87 new cases are diagnosed each day. Adult epilepsy places a substantial burden on the NHS and leads to 60,000 A&E and 40,000 hospital admissions in England.

People with epilepsy are likely to be at risk of physical, psychological and social issues that can impact self-esteem, families, relationships, leisure and working life. Early intervention can help to reduce the risk of irreversible disability and premature death.

Professor Charlotte Lawthom, Consultant Neurologist at Aneurin Bevan Health Board, said: “Adult epilepsy can be a challenging and debilitating condition which creates key challenges for people affected and the health system in Great Britain.

“Despite not being specifically mentioned in the NHS Long Term plan the proportion of adults living and dying with epilepsy is increasing meaning it is important that new solutions to better manage the condition become available.”

Cenobamate was discovered by SK Biopharmaceuticals and SK Life Science and was approved by the FDA for the treatment of partial-onset seizures in adults in 2019 and is commercially available in the U.S under the brand name Xcorpi.

Cenobamate is a novel small molecule that provides a dual, complementary mechanism of action aimed at treatment of seizures. Cenobamate at clinically relevant concentrations, acts both as a positive allosteric modulator of GABA receptors at a non-benzodiazepine binding site and preferentially blocks the persistent sodium current. The dual mechanism of action of cenobamate suggests that it has the potential to both prevent seizure initiation and limit seizure spread.

Final advice on cenobamate from NICE and the Scottish Medicine Consortium are expected to be published later in the year and early 2022 respectively.

Kat Jenkins

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