Takeda's Kynteles indicated for first-line treatment

MFDS accepts application to expand Kyntele’s indication for the first-line treatment targeting ulcerative disease and Crohn’s disease

Kynteles would be rubbing shoulders with tumor necrosis factor-alpha (TNFα)-antagonist in treating ulcerative colitis and Crohn’s disease.

 

Takeda Pharmaceuticals Korea (CEO Moon Hee-seok) official stated on Jan.

 

15, ulcerative colitis and Crohn’s disease treatment Kynteles (vedolizumab) won Korean Ministry of Food and Drug Safety’s (MFDS) approval on an indication for a first-line treatment.

 

According to the approval, Kynteles would be available from Jan.

 

15 for prescription on treating patients with ulcerative colitis and Crohn’s Disease after having to fail in remission by conventional treatment (with corticosteroid or immune therapy).

 

This means the treatment can be used, on the same treatment level as TNFα-antagonist and other biological drugs, to treat patients with inflammatory bowel diseases.

 

The two most common forms of inflammatory bowel diseases, ulcerative colitis and Crohn’s disease, tend to relapse and remit repetitively.

 

Studies found half of patients with inflammatory bowel diseases faced limits to their treatment so far having chronic, relapsed or worsened symptoms, damaged digestive systems and induced complications.

 

Besides clinical remission, intestinal mucosal healing is globally emerging as a new treatment target for inflammatory bowel disease.

 

Kynteles is a gut-selective treatment designed to specifically antagonize the α4β7 integrin, a cause of intestinal inflammation, and to inhibit the binding of α4β7 integrin.

 

Unlike existing treatments possibly increasing risk of tuberculosis and infection, Kyntelels’ efficacy as systemic immunosuppressant has not been confirmed.

 

According to GEMINI LTS study result, the vedolizumab drug demonstrated long-term effectiveness and safety profile in patients with ulcerative colitis and Crohn’s disease, observing clinical remission maintained up to 152 weeks.

 

And in Phase 3b VERSIFY study testing the treatment’s efficacy in 101 patients with severe Crohn’s disease, 15 percent and 12 percent of patients treated with Kynteles showed complete mucosal healing and endoscopic remission, respectively.

 

In a recent study, Kynteles demonstrated statistically superior clinical remission compared to conventional TNF-α antagonist.

 

Comparing patient groups either intravenously injected with Kynteles or subcutaneously injected with Humira (adalimumab), VARSITY study found 31.3 percent of Kynteles group reached clinical remission at week 52, but only 22.5 percent of Humira group did.

 

President of Korean Association of the Study of Intestinal Diseases (KASID), Kim Joo Sung claimed, “In Korea as of 2018, over 40,000 people were diagnosed with ulcerative colitis and 20,000 people with Crohn’s disease, and their prevalence rates have been soaring fast lately in Asian region including Korea.

 

As the diseases require long-term treatment, alleviating symptoms are not sufficient, but rather the patients should also improve mucosal healing and treat their inflammatory bowel diseases considering safety profile of drugs.”