ReqMed received approval to manufacture and market Cystadan® bulk powder in Japan on January 17, 2014, for the treatment of (to treat ) homocystinuria, and started sales on May 27, 2014. The product has sold to date.
Betaine is a drug for the treatment (treating)of homocystinuria, a disease in which a large amount of homocysteine, generated in excess due to an inborn genetic abnormality, is excreted into the urine. The drug is already marketed in Europe by Orphan Europe SARL and in the U.S. (approved in the U.S. in 1996 and in Europe in 2007). Cystadane is among a list of substances designated by the “Study Group on Unapproved Drugs” (currently the “Study Group on Unapproved Drugs and Off-label Drugs with High Medical Needs”) to be developed urgently as drugs. The “Study Group on Unapproved Drugs” was established in January 2005 by the Ministry of Health, Labour and Welfare to identify unapproved drugs, which are substances that have not been developed as drugs due to reasons such as the small number of domestic patients despite their use in the treatment of diseases, in need to be urgently developed from the standpoint of national health.