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Find Clinical Drug Pipeline Developments & Deals for Filgotinib
Alfasigma completed acquisition of Jyseleca (filgotinib), which provides European and UK Marketing Authorizations. It is used for the treatment of moderate to severe rheumatoid arthritis.
The agreement aims to transfer Galapagos’ Jyseleca (filgotinib maleate) business to Alfasigma, marking a significant milestone in its transformation into an innovative biotechnology company with a pipeline aimed for immunology and oncology.
Jyseleca (filgotinib) inhibits the action of Janus kinase enzymes, which are involved in the inflammation that causes the symptoms of active axial spondyloarthritis and some other conditions.
Jyseleca (filgotinib) inhibits the action of Janus kinase enzymes, which are involved in the inflammation that causes the symptoms of rheumatoid arthritis and some other conditions.
Jyseleca (filgotinib) inhibits the action of Janus kinase enzymes, which are involved in the inflammation that causes the symptoms of rheumatoid arthritis and some other conditions.
Jyseleca (filgotinib) is the only 2nd generation JAK inhibitor with JAK1 preferential inhibition of both approved doses, as well as the possibility of treating with the lowest effective dose in both RA and UC.
Filgotinib is marketed as Jyseleca (200mg and 100mg tablets) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).
Type II variation application was supported by interim data on demonstrated a prespecified sperm decrease at the timepoints from ongoing MANTA and MANTA-RAy, investigating effect of Jyseleca (filgotinib) use on semen parameters and sex hormones in adult patients.
The study showed that Jyseleca 200mg was well-tolerated and efficacious as induction and maintenance therapy with no new safety findings reported. The approval of Jyseleca in Japan is based on data from phase 2b/3 SELECTION study in patients with ulcerative colitis.
Jyseleca is a new oral JAK inhibitor (administered once daily). Jyseleca has been approved in Japan for the treatment of rheumatoid arthritis (including prevention of structural damage) who have responded inadequately to conventional therapies.
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