Gedeon Richter Media Approval for Alyssa® combination tablets (FSN-013), an Estetrol-based drug in Japan
Approval for Alyssa® combination tablets (FSN-013), an Estetrol-based drug in Japan
24/09/2024
Gedeon Richter Plc. (“Richter”) announces today that its partner, Fuji Pharma Co., Ltd. (“Fuji”) has received marketing approval of Alyssa® combination tablets (Development code: FSN-013), developed in Japan, to the Ministry of Health, Labour and Welfare (“MHLW”) for the scheduled indication of dysmenorrhea.

The approval triggers a milestone payment of EUR 10mn to Estetra SRL, a 100% subsidiary of Richter, under the agreement whereby Fuji holds development and commercialization rights for Alyssa® in Japan and the ASEAN region.

Alyssa® combination tablets is a dysmenorrhea treatment containing drospirenone and Estetrol (E4), a natural estrogen in-licensed by Fuji from Estetra SRL. Estetrol (E4) is a new active ingredient in Japan and has been confirmed to selectively act on estrogen receptors, and this selectivity is expected to provide a variety of benefits for patients.

Fuji is preparing for the launch FSN-013 combination tablets with tradename Alyssa® to provide a new treatment option for dysmenorrhea patients and help more women live healthier and more energetic lives.