Posted by Michael Wonder on 24 Jan 2021
BioCryst announces approval of Orladeyo (berotralstat) in Japan for the prophylactic treatment of hereditary angioedema
22 January 2021 - BioCryst Pharmaceuticals today announced that the Ministry of Health, Labor and Welfare in Japan has granted marketing and manufacturing approval for oral, once daily Orladeyo (berotralstat) 150 mg for prophylactic treatment of hereditary angioedema in adults and paediatric patients 12 years and older.
Orladeyo is the first and only prophylactic hereditary angioedema medication approved in Japan. One capsule of Orladeyo per day works to prevent attacks of hereditary angioedema by decreasing the activity of plasma kallikrein.
Orladeyo will be commercialised in Japan by BioCryst’s partner, Torii Pharmaceutical. OrphanPacific is BioCryst’s representative partner in Japan and holds the marketing authorisation.
Torii will launch Orladeyo in Japan following the successful completion of BioCryst’s pricing negotiations with the Japanese National Health Insurance System.
