DGAP-News: PAION AG / Key word(s): Regulatory Approval
PAION RECEIVES UK MHRA APPROVAL OF BYFAVO(R) (REMIMAZOLAM) FOR PROCEDURAL SEDATION
Dr. Jim Phillips, CEO of PAION AG, commented: "We are excited that the MHRA has approved Byfavo(R). Our UK launch can now be prepared for the second half of 2021 by our British affiliate led by Katja Lundell and her team. The UK is one of Europe's strongest markets & we have good expectations for the uptake of Byfavo(R) in this key market."
Remimazolam is also in development for general anesthesia. Based on the positive results in the European Phase III trial in this indication, PAION plans to submit an extension variation to the Marketing Authorization for remimazolam for general anesthesia by the end of 2021. The approval process for an extension variation is generally faster than for a Marketing Authorization Application (MAA).
Remimazolam is approved in the U.S., the EU/EEA/UK and China for procedural sedation and in Japan and South Korea for general anesthesia.
In addition to procedural sedation and general anesthesia, intensive care unit (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, in South Korea (brand name ByfavoTM) and Southeast Asia with Hana Pharm and in Taiwan with TTY Biopharm. For all other markets except Western Europe, remimazolam is available for licensing.
In addition to Byfavo(R) (remimazolam), PAION is preparing to launch the two products GIAPREZA(R) (angiotensin II) and XERAVA(R) (eravacycline) in Europe. GIAPREZA(R) is 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. XERAVA(R) is a novel fluorocycline type of antibiotic indicated 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).
29.06.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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