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.
Dr. Jim Phillips, CEO at PAION AG, commented: 'This positive CHMP opinion for Byfavo(R) brings us closer to our ambition to delivering the first innovative treatment option for sedation and anesthesia in Europe in more than 30 years. We can now further plan to make the product available to patients and physicians in first European markets with a plan for launches in procedural sedation in the second half of 2021.'
Remimazolam is approved in the U.S. and China for procedural sedation and in Japan and South Korea for general anesthesia. In Europe, PAION submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in procedural sedation in November 2019.
In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation is another possible indication for remimazolam.
Remimazolam is partnered in the U.S. (brand name BYFAVOTM) with Acacia Pharma, in Japan (brand name Anerem(R)) with Mundipharma, in China (brand name Ruima(R)) with Yichang Humanwell, in Canada with Pharmascience, in Russia/CIS, Turkey and the MENA region with R-Pharm, and in South Korea (brand name BYFAVOTM) and Southeast Asia with Hana Pharm.
In Europe, PAION is seeking approval of Byfavo(R) (remimazolam) for general anesthesia and for procedural sedation. PAION submitted a Marketing Authorization Application (MAA) for procedural sedation in November 2019. It is planned to commercialize Byfavo(R) once approved in Europe together with GIAPREZA(TM) as a vasoconstrictor indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies, and XERAVA(TM) for the treatment of complicated intra-abdominal infections in adults.
PAION's mission is to be a leading specialty pharmaceutical company in the fields of anesthesia and critical care by bringing novel products to market to benefit patients, doctors and other stakeholders in healthcare.
PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).
29-Jan-2021 CET/CEST The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
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|EQS News ID:||1163731|
|End of Announcement||DGAP News Service|
1163731 29-Jan-2021 CET/CEST