Self-administered Kynteles lands at general hospitals

The subcutaneous injection formulation can be prescribed at general hospitals in Korea

Passes drug committees of major medical institutions including SMC and AMD

Listed for reimbursement last year...demonstrated same clinical remission as its intravenous injection version

The self-injectable formulation of the inflammatory bowel disease treatment ‘Kynteles’ can now be prescribed at general hospitals in Korea.

 

According to industry sources, the subcutaneous injection formulation of Takeda Pharmaceuticals Korea’s Kynteles (vedolizumab) has passed the drug committee (DC) reviews in tertiary hospitals such as Samsung Medical Center and Seoul Asan Medical Center and other general hospitals including Kyungpook National University Hospital, Yeungnam University Medical Center, and Inje University Haeundae Paik Hospital.

 

The company has been quickly expanding its prescription area after the drug was listed for reimbursement in December last year.

 

Kynteles is reimbursed in Korea if the patient ▲writes a ‘patient administration journal’ that is managed by his/her healthcare institution within 14 weeks of the first administration.

 

For long-term prescriptions, ▲up to 2 weeks’ worth of prescriptions is allowed per prescription upon discharge, and up to 4 weeks’ worth of prescriptions is allowed for outpatient care patients.

 

Also, up to 8-12 weeks’ worth of administration is approved for reimbursement in patients who show stable disease activity after 24 weeks of administration with no side effects.

 

The subcutaneous injection formulation of Kynteles, ‘Kynteles Prefilled Pen inj.’ can be self-administered by the patient without visiting hospitals, and was approved for the same efficacy and effect as ‘Kynteles Inj,’ the intravenous injection formulation, in Korea on February 17.

 

In addition to the existing strength held by the intravenous injection formulation of having a short administration period of 30 minutes, the added reimbursement of the subcutaneous injection formulation has provided a wider treatment option for Korean patients.

 

The subcutaneous formulation of Kynteles showed a similar rate of clinical remission to that of the intravenous injection in the VISIBLE trials.

 

In the VISIBLE 1 study that was conducted on adult patients with ulcerative colitis, the subcutaneous formulation showed comparable improved improvement with the intravenous formulation in terms of efficacy, safety profile, and tolerability.

 

The VISIBLE 2 trial that evaluated the subcutaneous formulation as a maintenance treatment in adults with Crohn’s disease also confirmed the significant improvement in results, demonstrating the new formulation’s effect as a maintenance treatment.

 

Kynteles is a biological agent used to treat patients with moderate-to-severe active ulcerative colitis or Crohn's disease.

 

As the only anti-integrin therapy among inflammatory bowel disease treatments, the drug owns a safety profile that does not cause systemic immunosuppressive activity.