The Ministry of Food and Drug Safety (MFDS) will implement changes to approval for Janus Kinase (JAK) inhibitors, recommending low dosages when used to treat high-risk patients.

This is a follow-up measure to the changes to the efficacy and effectiveness section for high-risk patient treatment in 2022.

On August 30th, the MFDS posted on the website that it has started collecting opinions on the revised approval for JAK inhibitors based on reviewing the safety information from the European Medicines Agency (EMA).

The posting indicates that the updated guidelines for tofacitinib in ulcerative colitis now include a recommendation against using the 10 mg maintenance dos