Limited indications of JAKI for high-risk groups

Request for a clear statement from the Central Pharmaceutical Affairs Review Committee of the MFDS for insufficient effectiveness of existing treatments

It will be changed in July through procedures such as inquiry of opinions and prior notice

It was confirmed that the opinions of the Central Pharmaceutical Affairs Council members were also mixed over the limited use of Janus kinase Inhibitors, which is used as a treatment for inflammatory diseases.

 

The MFDS announced on the 15th that high-risk patients aged 65 or older, high-risk cardiovascular groups, and malignant tumors will be able to use them only when they are insufficient with existing treatments.

 

65 items of JAK inhibitors (Tofacitinib, Baricitinib, Upacitinib, Abrocitinib, and Filgotinib) were licensed in Korea.

 

According to the minutes of the Central Pharmaceutical Affairs Council held last month, the committee members gathered opinions on the current status of foreign countries, related studies, and the need to manage JAK inhibitors.

 

As a result, there were three members who did not need to change their efficacy, and only one member said that the effectiveness of all JAK inhibitors needed to be changed.

 

Seven members agreed to change the efficacy effect of Tofacitinib and Baricitinib, which have clear grounds in the United States and Europe.

 

However, it was pointed out by the chairman that if the efficacy is changed only for Tofacitinib and Baricitinib, the prescriptions for other ingredients of the same indication, such as Upacitinib and Filgotinib, are expected to increase at the clinics.

 

It is due to concerns that measures to change the effectiveness of obtaining sufficient data on side effects by obtaining permission first could instill a perception that other ingredients approved late are safer ingredients.

 

"Considering various issues, further discussions are needed on the range of ingredients that change efficacy, such as the application of all JAK inhibitors or two ingredients," the chairman said.

 

A member of the committee said, "It is said to be the same category, but it is known that the mechanism of action is slightly different," adding, "It would be good to maintain restrictions on efficacy based on the evidence so far and apply precautions for use to all drugs." The MFDS said, "We will push for a change in usage precautions that describe major cardiovascular risks for all JAK inhibitors." The MFDS added, "We will change the permission for Tofacitinib and Baricitinib in consideration of confusion from clinics, but we will take further measures to include the remaining three ingredients." Meanwhile, after distributing dear healthcare professional letter in September last year, the MFDS confirmed that patients with cardiovascular risk factors administered Tofacitinib and Baricitinib increased their risk of cardiovascular abnormalities compared to the TNF inhibitor group.

 

The United States restricts all JAK inhibitors to use only in patients who do not respond appropriately to other treatments, such as one or more TNF inhibitors, as well as in high-risk patients.

 

For Tofacitinib, Europe restricts the use of high-risk groups only when there is no appropriate treatment alternative, and considers the need for additional measures for other JAK inhibitors.

 

The MFDS plans to order the change of permission in July through procedures such as inquiry of permission change (proposal) opinion and advance notice.