EC grants marketing authorisation to Angelini Pharma’s epilepsy treatment

pharmafile | April 1, 2021 | News story | |   

Angelini Pharma have announced that the European Commission (EC) have granted marketing authorisation for Ontozry (cenobamate) for the treatment of focal-onset seizures in adults.

Ontozry will be used as an adjunctive treatment for focal-onset seizures, with or without secondary generalisation, in adult patients who have not been adequately controlled despite a history of treatment with at least two anti-epileptic medicinal products.

The EC marketing authorisation is valid in all EU member states plus Iceland, Norway, and Liechtenstein. Cenobamate is currently being reviewed via the reliance route by the MHRA.

The EC’s approval is based upon the successful results from three key trials which involved over 1,900 patients, the results of which have been published in The Lancet Neurology.

Agnese Cattaneo, Chief Medical Officer at Angelini Pharma, said: “There are an estimated six million people in Europe with epilepsy and approximately 40% of adult patients with focal epilepsy have inadequate control of seizures after treatment with two anti-seizure medications.

“This approval marks an important step forward in the treatment of focal-onset seizures in adults with epilepsy. It is very important that patients have a new treatment option because seizures can have devastating effects on their lives.”

The main symptom of epilepsy is repeated seizures, these are sudden bursts of electrical activity in the brain that temporarily affect how it functions. Seizures can affect people in different ways, depending on which part of the brain is involved. Some seizures cause the body to jerk and shake, while others cause problems like loss of awareness or unusual sensations.

A diagnosis of epilepsy therefore confers significant disability on the individual, including physical, psychological, and social issues that can negatively impact all areas of a person’s life.

Cenobamate was discovered by SK Biopharmaceuticals and SK Life Science, and was approved by the FDA for the treatment of partial-onset (focal) seizures in adults in 2019. It is commercially available in the US under the brand name XCOPRI CV.

Jeong Woo Cho PhD, President and CEO of SK Biopharmaceuticals and SK Life Science, said: “The approval by the European Commission is another major milestone in our efforts to increase access to cenobamate and to support patients with a much-needed new treatment option.

“As a fully-integrated global pharmaceutical company, we are committed to discovering, developing and delivering new treatment options for epilepsy and other central nervous system disorders to people around the world.”

Kat Jenkins


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