DGAP-Adhoc PAION RECEIVES POSITIVE CHMP OPINION RECOMMENDING APPROVAL OF BYFAVO(R) (REMIMAZOLAM) IN PROCEDURAL SEDATION
DGAP-Ad-hoc: PAION AG / Key word(s): Miscellaneous
PAION RECEIVES POSITIVE CHMP OPINION RECOMMENDING APPROVAL OF BYFAVO(R) (REMIMAZOLAM) IN PROCEDURAL SEDATION
- Positive CHMP opinion based on the data from a comprehensive clinical program in procedural sedation in adult patients undergoing bronchoscopy or colonoscopy
- Final decision on MAA expected in the first half of 2021
Aachen (Germany), 29 January 2021 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Byfavo(R) (remimazolam) in procedural sedation in adult patients.
The European Commission will review the CHMP recommendation and a final decision on the Marketing Authorization Application (MAA) for Byfavo(R) in the EU (including European Economic Area (EEA) countries) is expected in the first half of 2021. The UK Medicines & Healthcare products Regulatory Agency (MHRA) will also consider the positive opinion for a potential approval in the United Kingdom.
End of inside information
Information and Explanation of the Issuer to this News:
The positive CHMP opinion for Byfavo(R) (remimazolam) is based on the clinical program in procedural sedation in adult patients undergoing bronchoscopy or colonoscopy. Remimazolam was approved in China and in the U.S. in July 2020 for the induction and maintenance of procedural sedation in adults.
Remimazolam is also in development for general anesthesia in Europe, and was approved in Japan and South Korea for general anesthesia. Assuming approval in procedural sedation by the European Commission, PAION plans to submit an extension of the marketing authorization for remimazolam for general anesthesia based on the recently announced positive EU Phase III data.