Gilead withdraws submission for Jyseleca

TGA

24 May 2021 - Decision should not come as a major surprise given FDA rejection last year.

The TGA has published an AusPAR for filgotinib maleate (Jyseleca) for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

The submission was withdrawn on 27 February 2021.

Read TGA AusPAR for Jyseleca

Michael Wonder

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Michael Wonder

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Outcome , Medicine , Australia , Dossier