In the past, filgotinib (Jyseleca) has largely been used to treat patients with rheumatoid arthritis (RA). However, researchers hypothesized that the treatment could be beneficial in other indications. Following the Phase 2b/3 SELECTION clinical trial, Galapagos NV, EA Pharma Co., Ltd., Eisai Co., Ltd., and Gilead Sciences K.K. shared via news release that Jyseleca had been approved in Japan for the treatment of moderate-to-severe ulcerative colitis (UC).
Originally discovered and developed by Galapagos using their proprietary drug discovery platform, filgotinib (Jyseleca) is an orally administered JAK1 inhibitor. Given once each day, Jyseleca works to reduce inflammation and symptoms associated with UC. Outside of UC and RA, researchers are also evaluating this treatment as a potential therapeutic option for Crohn’s disease. Learn more about Jyseleca here.
Researchers evaluated the safety, efficacy, and tolerability of Jyseleca for ulcerative colitis within the Phase 2b/3 SELECTION trial. In particular, the treatment was examined for those with treatment-averse UC. Therefore, this drug is filling a huge unmet need. The study found that 200mg Jyseleca was safe, effective in maintenance, and well-tolerated.
Ulcerative Colitis (UC): An Overview
Ulcerative colitis (UC) lives under the umbrella of inflammatory bowel disease (IBD). This chronic inflammatory condition causes the formation of sores and ulcers in the large intestine and rectum. While doctors are not sure exactly what causes UC, many consider it to result from immune dysfunction. Additional risk factors include being younger than 30 or older than 60, having a family history of IBD, or having Ashkenazi Jewish heritage. Typically, symptoms of UC progress over time. These include:
- Rectal bleeding
- Unintended weight loss
- Nausea and vomiting
- Bloody stool
- Bowel urgency or inability to pass a bowel movement despite urgency
- Abdominal pain and cramping
- Anemia (low red blood cell count)
- Joint pain