European Commission grants Marketing Authorisation for filgotinib (Jyselca) for treatment of moderate to severe active rheumatoid arthritis
Filgotinib is a once-daily, oral, JAK1 inhibitor, recently approved in adults who have responded inadequately to, or who are intolerant to one or more DMARDs. Approval was based on the FINCH studies, which showed improvements in ACR20/50/70 criteria, vs placebo or methotrexate.
Source:
Biospace Inc.
SPS commentary:
In August 2020, the US FDA have issued a Complete Response Letter requesting data from the MANTA and MANTA-RAy studies (designed to assess filgotinib´s impact on sperm) before completing its review of the NDA. They also express concerns regarding the overall benefit/risk profile of the 200 mg dose.