Proveca to seek re-examination of CHMP's negative opinion on CT001/KemSu
Proveca intends to request a re-examination of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) negative opinion on its paediatric use marketing authorisation application for CT001/KemSu.
Proveca announced its intention to request a re-examination of a negative opinion issued by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The opinion relates to the company's application for a Paediatric Use Marketing Authorisation (PUMA) for CT001/KemSu, an intranasal formulation of sufentanil/ketamine.
The CHMP's negative opinion concerns the treatment's potential as an option for children experiencing moderate to severe acute pain. Proveca plans to use the established EMA procedures to formally request a review of the CHMP's earlier decision.
Both Proveca and its partner Cessatech have stated their commitment to continued close collaboration with the EMA throughout the re-examination process. The companies maintain that CT001/KemSu represents a significant potential treatment avenue for pediatric patients suffering from acute pain.
The re-examination process is expected to commence shortly, with further details on the timeline to be announced at a later date.