The European Commission ( EC ) has granted marketing authorization for Jyseleca ( Filgotinib 200 mg and 100 mg tablets ), a once-daily, oral, JAK1 inhibitor for the treatment of adults with moderate to severe active rheumatoid arthritis who have responded inadequately to, or are intolerant to, one or more disease modifying anti-rheumatic drugs ( DMARDs ).
Jyseleca may be used as monotherapy or in combination with Methotrexate ( MTX ).
Rheumatoid arthritis is a chronic, progressive, systemic, inflammatory disease that can lead to significant and irreversible joint destruction, pain and functional impairment.
Almost 3 million people in Europe are living with rheumatoid arthritis, many of whom do not achieve long-term symptom control, which can lead to more frequent symptom flares and disease progression and can significantly impact their quality of life.
The EC’s decision is supported by data from over 3,500 patients treated with Jyseleca across the phase 3 FINCH and phase 2 DARWIN programs.
In the FINCH studies, Jyseleca consistently achieved ACR20/50/70 criteria, with improvements in all individual ACR components compared with placebo or Methotrexate.
A significantly higher proportion of patients treated with Jyseleca 200 mg plus Methotrexate or other conventional synthetic disease-modifying anti-rheumatic drug(s) ( csDMARD ) achieved low disease activity and/or remission ( DAS28-CRP less than or equal to 3.2 and DAS28-CRP less than 2.6 ) at weeks 12 and 24 compared with placebo or Methotrexate.
In patients who had an inadequate response to Methotrexate, treatment with Jyseleca plus Methotrexate achieved statistically significant inhibition of progression of structural joint damage compared to placebo plus Methotrexate, as assessed using the modified Total Sharp Score ( mTSS ) at week 24.
In the DARWIN 3 phase 2, open-label, long-term extension study, durable ACR20/50/70 responses were maintained for up to three years in patients who received Jyseleca 200 mg as monotherapy or with Methotrexate.
Across the FINCH and DARWIN trials, the most common adverse reactions were nausea, upper respiratory tract infection, urinary tract infection and dizziness.
Rates of herpes zoster and pneumonia were uncommon.
The frequency of serious infections in the Jyseleca 200 mg group was 1.0% compared to 0.6% in the placebo group.
In an integrated safety analysis in seven clinical trials the rates of major adverse cardiac events ( MACE ) and venous thromboembolism ( VTE ) with Jyseleca were comparable to placebo.
The rates of serious infections remained stable with long-term exposure. ( Xagena )
Source: Gilead, 2020