Published: 7/24/2026 8:39:30 AM
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The European Medicines Agency's scientific committee CHMP has issued a negative opinion on Proveca's application for a PUMA approval for KemSu, previously CT001, for the treatment of acute pain in children aged 1-17 years. This is stated in a press release.Proveca will request a review according to EMA's process. Proveca is Cessatech's commercialization partner for KemSu and is intended to become the holder of the marketing authorization for the product in Europe.Cessatech and Proveca state that they still see a positive benefit-risk profile and will cooperate with EMA during the review, which is expected to take several months."Together with our partner Proveca, we intend to request a review of CHMP's opinion and will continue to work constructively with EMA, with the goal of making KemSu available to children who need new treatment alternatives for the management of acute pain. The review process is expected to take several months", says Jes Trygved, CEO of Cessatech.
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