JAK inhibitor 'Jyseleca' approved for use at 'Big 5'

hospitals

Approved at tertiary general hospitals, including St. Mary's Hospital

Switching approved, starting in October…the drug sales are expected to benefit from this approval

Product photo of Jyseleca.

The JAK inhibitor 'Jyseleca' has been successfully introduced to general hospitals.

 

Sources said Jyseleca, the fifth JAK inhibitor in South Korea, has passed the drug committees (DC) of 'Big 5' tertiary hospitals, including Samsung Medical Center, Seoul University Hospital, Seoul St.

 

Mary's Hospital, Seoul Asan Medical Center, and Sinchon Severance Hospital.

 

The drug also passed DC of medical centers, including Kangbuk Samsung Hospital, Korea University Anam Hospital, Cha University Bundang Medical Center, Sejong Chungnam National University Hospital, Ulsan University Hospital, Konkuk University Hospital Chungju Hospital, and Hanyang University Medical Center, as well as national university hospitals in major cities.

 

Considering that it is the fifth approved JAK inhibitor in South Korea, it has quickly become available for prescription at hospitals following reimbursement listing in November last year.

 

Jyseleca’s initial indication for reimbursement was for the treatment of rheumatoid arthritis and moderately to severely active ulcerative colitis.

 

Its reimbursement criteria are set for individuals who have had an inadequate response to conventional therapies or have no drug tolerance to each disease.

 

For those who are over 65 years old, the criteria are set for individuals who have had an inadequate response to TNF-α inhibitors or have no drug tolerance.

 

In South Korea, JAK inhibitors, such as 'Xeljanz (tofacitinib),' 'Olumiant (baricitinib),' and 'Rinvoq (upadacitinib),' are being prescribed.

 

It is to be watched whether Jyseleca would have a competitive advantage over these drugs.

 

Since their launch, these drugs have been expanding indications and reimbursement criteria.

 

Xeljanz additionally secured indications for ulcerative colitis and psoriatic arthritis, and latecomers, such as Rinvoq, are also expanding prescription areas in autoimmune diseases, including atopic dermatitis, Chron’s disease, and ankylosing spondylitis.

 

Since their launch, these drugs have been expanding indications and reimbursement criteria.

 

Xeljanz additionally secured indications for ulcerative colitis and psoriatic arthritis, and latecomers, such as Rinvoq, are also expanding prescription areas in autoimmune diseases, including atopic dermatitis, Chron’s disease, and ankylosing spondylitis.

 

Consequently, patients are expected to have improved treatment options for rheumatoid arthritis.

 

Of course, the use of JAK inhibitors, including Jyseleca, will substantially increase.

 

According to the market research firm UBIST, the JAK inhibitor outpatient prescription market size for the first half of 2023 was KRW 27.5 billion, up by 54% from KRW 17.8 billion year over year.

 

Meanwhile, Jyseleca is a selective ATP-competitive and reversible JAK1 inhibitor.

 

JAK1 transmits signals from a cytokine, and it is regarded as the key target for the treatment of rheumatoid arthritis.

 

Recently launched treatments inhibit JAK2 or JAK3, depending on their mechanism.

 

However, there are concerns that adverse reactions may occur, as two signaling pathways regulate immune cell proliferation and homeostasis.

 

The FINCH1, FINCH2, and FINCH3 Phase 3 trials have demonstrated the effectiveness of Jyseleca.

 

In the FINCH1 trial, Jyseleca 200 mg treatment in patients with moderately to severely active rheumatoid arthritis reached ACR20 at 20 weeks more quickly despite continued treatment with MTX.