Sedana Medical files submission for paediatric indication
Sedana Medical AB (publ) announces that the company has submitted a Type II variation with the aim of including the paediatric population (3-17 years) into the existing Sedaconda® indication for inhaled sedation of mechanically ventilated patients in Europe.
The submission is based on the results of the IsoCOMFORT trial, a randomised active-controlled assessor-blinded study comparing the efficacy and safety of sedation with inhaled isoflurane, administered via the company’s medical device Sedaconda ACD-S, with intravenous midazolam in mechanically ventilated patients 3 to 17 years old.
Sedana Medical´s objective of the IsoCOMFORT trial was two-fold: to secure extended data exclusivity and market protection for Sedaconda® (isoflurane)’s main indication in adult patients and to obtain an approval for sedation of mechanically ventilated children in intensive care.
In November, the European Medicines Agency’s Paediatric Committee issued a positive opinion regarding the compliance with the company’s Paediatric Investigation Plan. This confirmed data exclusivity and market protection for Sedaconda (isoflurane) until 2031.
Now, the Type II variation to extend the indication to include paediatric patients of 3-17 years has been submitted to the Reference Member State (RMS) Germany and 15 Concerned Member States (CMS) in Europe. Type II variations follow a standard procedure, which foresees a review period of 120 days plus a maximum of 150 days to answer questions. Sedana Medical therefore expects End of Procedure in Q3 2024, after which the national approval processes will follow. For the adult indication, those lasted between 1 and 2 months for the majority of countries.
“I would like to thank my team for successfully completing the filing of our paediatric indication in line with our ambitious time plan.”, says Johannes Doll, President and CEO of Sedana Medical. “Children in intensive care are a vulnerable and difficult-to-treat patient population, with a clear need for alternative sedation methods. Based on our IsoCOMFORT results, we are hoping to receive an approval, so that these patients can benefit from the advantages we saw in the study, such as lower opioid requirements and faster time to extubation.”
The main results of the IsoCOMFORT trial are available on the Clinical Trials Registry EudraCT.
For more information, see:
https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-000578-31/results
For additional information, please contact:
Johannes Doll, CEO, +46 (0)76 303 66 66
Johan Spetz, CFO, +46 (0)730 36 37 89
[email protected]
About Sedana Medical
Sedana Medical AB (publ) is a pioneer medtech and pharmaceutical company focused on inhaled sedation to improve the patient’s life during and beyond sedation. Through the combined strengths of the medical device Sedaconda ACD and the pharmaceutical Sedaconda (isoflurane), Sedana Medical provides inhaled sedation for mechanically ventilated patients in intensive care.
Sedana Medical has direct sales in Benelux, France, Germany, Great Britain, the Nordics, and Spain. In other parts of Europe as well as in Asia, Australia, Canada, and South- and Central America, the company works with external distributors.
Sedana Medical was founded in 2005, is listed on Nasdaq Stockholm (SEDANA) and headquartered in Stockholm, Sweden.