FDA ‘yes’ brings SK Biopharma’s seizure drug one step closer to Europe
PharmaTimes | November 25, 2019
The US Food and Drug Administration (FDA) has given Arvelle Therapeutics’ Xcopri (cenobamate tablets) 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.