On May 3rd, the Ministry of Food and Drug Safety (MFDS) newly designated 3 drugs including ‘asciminib,' which is used for the treatment of rare leukemia and breast cancer, as orphan drugs. Also, MFDS announced that it will extend the indication for ‘ibrutinib,’ and designate drugs used for neonatal hypoxic-ischemic encephalopathy as development-stage orphan drugs.

The orphan drug designation is given by the Minister of Food and Drug Safety, to drugs that are used to diagnose or treat rare diseases with no alternatives or with a significantly improved safety and efficacy compared to existing alternatives.

The MFDS operates the ‘orphan drug designation system’ to prompt