The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of filgotinib (Jyseleca) for moderate to severe active rheumatoid arthritis (RA) in adults who have responded inadequately to or are intolerant of one or more disease-modifying antirheumatic drugs.
Filgotinib is an investigational selective Janus kinase 1 inhibitor taken once daily. It may be used alone or in combination with methotrexate (MTX). Once approved, it will be available as 100-mg and 200-mg tablets, according to an EMA news release.
The CHMP's recommendation was supported by the phase 3 FINCH and phase 2 DARWIN programs, which included data regarding 4544 patient-years of experience with filgotinib (100 mg and 200 mg once daily) from patients with RA.
"All three FINCH trials, involving a broad range of patients, met their primary endpoints," the company said in a news release.
Results of the FINCH 1 trial were reported in June 2019 at the European League Against Rheumatism (EULAR) 2019 Congress.
Results of the FINCH 2 trial were published a month later in JAMA.
In clinical testing, filgotinib "consistently" achieved American College of Rheumatology 20/50/70 targets and other relevant treatment targets, such as disease activity score of <2.6 in 28 joints using C-reactive protein, the company said.
Filgotinib also inhibited the progression of structural joint damage, as assessed by modified total Sharp score, compared with placebo.
The clinical safety profile of filgotinib was consistent when taken alone or with MTX.
Rates of serious infections and herpes zoster were generally similar to those of the tumor necrosis factor inhibitor adalimumab and MTX. Rates of major adverse cardiac events and venous thromboembolism were infrequently reported.
The CHMP positive opinion will now be reviewed by the European Commission.
Detailed recommendations for filgotinib will be provided in the summary of product characteristics, which will be published in the European public assessment report. It will also be made available in all official European Union languages if marketing authorization is granted by the European Commission.
Cite this: EMA Panel Backs Filgotinib (Jyseleca) for Rheumatoid Arthritis - Medscape - Jul 29, 2020.