Published: 12. September, 2023
On 12 September – Cessatech A/S (“Cessatech” or “the Company”) announces that EMA’s Paediatric…
On 12 September – Cessatech A/S (“Cessatech” or “the Company”) announces that EMA’s Paediatric Committee (PDCO) has agreed to the Paediatric Investigational Plan (PIP) for CT002 for procedural sedation. CT002 is the second asset in Cessatech’s pipeline that has been selected for development.
- The Paediatric Committee (PDCO) under The European Medicines Agency (EMA) has agreed to the Paediatric Investigational Plan (PIP) for CT002
- CT002 is the second asset in Cessatech’s pipeline that has secured a PIP aimed at ensuring the necessary data to support a future authorisation for use in children
- CT002 is developed to address the unmet medical need of a non-invasive sedative procedure for children undergoing MRI scanning or other procedures requiring sedation
Jes Trygved, CEO, Cessatech
“We are very excited that EMA has agreed to the paediatric investigational plan for CT002 and look forward to progressing further with this second asset in Cessatech’s pipeline. Diagnostic imaging procedures in the paediatric population are increasing and so is the number of examinations where sedation or general anaesthesia is needed. Having discussed CT002 with several experts in the field there is no doubt that CT002 may serve the unmet medical need for a safe and easy to administer drug for procedural sedation in children. With the positive opinion from EMA’s PDCO for CT002, we have aligned expectations for a potential paediatric-use marketing authorization for the European market. We continue to work towards our purpose of rethinking child treatments”