Cessatech Addresses EMA's Refusal of KemSu Marketing Authorization
Cessatech released a Q&A addressing questions from investors following the European Medicines Agency's (EMA) July 23 refusal of marketing authorization for KemSu. The overview clarifies the company's perspective on the decision and outlines next steps.
Cessatech A/S issued a Question and Answer (Q&A) document on August 3, addressing investor inquiries regarding the European Medicines Agency's (EMA) refusal on July 23 to grant marketing authorization for KemSu (sufentanil/ketamine).
The Q&A aims to provide clarity on the reasons behind the EMA's decision and Cessatech's planned course of action. Investor questions focused on the efficacy data submitted and the company's interactions with regulatory bodies.
A key point addressed concerns the efficacy message presented to the EMA's Committee for Medicinal Products for Human Use (CHMP). Cessatech stated that the efficacy package integrates head-to-head data from adult studies with pediatric pharmacokinetic and pharmacodynamic (PK/PD) modeling. This approach was validated in study 0202, with the company asserting that studies 0208 and 0202 reach consistent conclusions.
Furthermore, the Q&A clarifies which regulatory committee, the Paediatric Committee (PDCO) or CHMP, agreed upon the study setup for pediatric trials. Cessatech provides its interpretation of this aspect of the regulatory process.
The company has indicated that further details regarding its next steps and any potential appeal processes will be communicated in due course. The EMA's refusal represents a significant setback for Cessatech's development efforts for KemSu.