FDA approves SK Biopharma’s seizure drug
FDA has given Arvelle Therapeutics’ Xcopri the go-ahead for partial-onset seizures in adults.
The emerging company, which is part of a subsidiary of SK Biopharmaceuticals, announced that it has also licensed exclusive rights to develop and commercialise the drug in Europe, with intent to file a Marketing Authorisation Application (MAA) in the first half of next year, based on Phase II and III trials.
The FDA approval was based on the same studies, which demonstrated a significant reduction in seizure frequency at all doses studied compared to placebo. Study 013 and 017 showed a statistically significant 56% reduction from baseline in seizure frequency and statistically significant responder rates in all doses, respectively.
The FDA approval has been hailed as a “critical step forward in our efforts to bring this important potential medicine to Europe” explained Mark Altmeyer, president and chief executive officer of Arvelle.
“We believe cenobamate could potentially be a welcome new treatment option for people living with this debilitating condition.”
There are currently an estimated six million people in Europe with epilepsy, and approximately 40% of adult patients with epilepsy have inadequate control of seizures after treatment with two AED regimens.