Gilead Sciences’ rheumatoid arthritis (RA) treatment Jyseleca has been given a recommendation from the UK’s National Institute of Health and Care Excellence (NICE).
Jyseleca (filgotinib) is an oral JAK inhibitor that can be administered as a monotherapy or used alongside another another common RA medicine called methotrexate.
Patients with moderate-to-severe RA will now be able to access the drug on the NHS in England, if they have responded inadequately to previous intensive therapy with two or more disease-modifying anti-rheumatic drugs (DMARDs).
“This is a landmark decision from NICE and represents a pivotal moment for the treatment of RA,” said James Galloway, consultant rheumatologist at King’s College London Hospital.
“While no single medicine works for everyone, the addition of Jyseleca is an important step forward that we believe will help more patients achieve remission, even when their disease is at a less advanced stage,” he added.
In phase 3 trials, Jyseleca was shown to be effective in reducing the symptoms of RA, including joint tenderness and swelling.
In one of these studies – FINCH 1 – the JAK inhibitor was compared to AbbVie’s TNF antibody Humira (adalimumab) or placebo – given on top of methotrexate – in patients with moderate-to-severe RA who weren’t responding to methotrexate alone.
Daily oral dosing with Jyseleca was significantly better than placebo in achieving a 20% improvement in symptoms (an ACR 20 response), the primary endpoint in the study, and matched the efficacy of Humira which is given by injection.
FINCH 3 compared Jyseleca alone or in combination with methotrexate as a front-line therapy for patients with moderate-to-severe RA. In this study, the combination was significantly better than methotrexate alone at helping patients achieve an ACR20 response.
In addition, Jyseleca monotherapy was as effective as methotrexate on the ACR20 measure, but was significantly better on the 50% improvement (ACR50) and 70% improvement (ACR70) scales.
In August 2020, the US Food and Drug Administration (FDA) rejected Gilead’s Jyseleca, handing the company a complete response letter (CRL).
In this CRL, the FDA asked for data from two ongoing clinical trials – MANTA and MANTA-Ray – investigating the effect of the 200mg dose of Jyseleca on sperm concentrations.
“The FDA has expressed concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose,” Gilead added in a statement.
Topline results from the MANTA and MANTA-Ray studies are expected in the first half of 2021, at which point Gilead is likely to refile Jyseleca with the FDA.