Galapagos has obtained marketing authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Jyseleca (filgotinib 200mg tablets) to treat ulcerative colitis (UC) in Great Britain.
Jyseleca is indicated for usage in moderately to severely active UC adult patients, with insufficient, lost response to or were not tolerant to either standard treatment or a biologic agent.
An oral preferential inhibitor of Janus Kinase 1 (JAK1), filgotinib is licenced and sold as Jyseleca in the region.
Galapagos discovered the oral therapy and is developing it in partnership with Gilead for UC, rheumatoid arthritis (RA) and Crohn’s disease (CD).
The submission was based on results from the Phase IIb/III SELECTION programme.
In November last year, the European Commission (EC) granted marketing authorization for the oral therapy for usage in UC patients.
Galapagos chief commercial officer Michele Manto said: “At Galapagos we are committed to bringing new and innovative medicines to healthcare professionals who are treating patients with UC and today we are one step closer to offering a new treatment option to thousands of patients living in Great Britain with UC, a chronic and debilitating disease.
“Together with the EC decision, this decision represents an important milestone in our plans to make Jyseleca available to eligible adult patients with UC across Europe.”
A life-long condition, UC causes inflammation of the colon and rectum’s mucosal lining.
Currently, Galapagos’ oral therapy is under review by the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan for the treatment of moderate to severe active UC.
Jyseleca is also marketed in the European Union, Great Britain and Japan to treat adult patients with moderate to severe active rheumatoid arthritis (RA).
It is intended for use in people with inadequate responses or who are not tolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).