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Autoimmune-Summaries: Daily Autoimmune Updates at a Glance

decodeMR Team
6 hours ago
2 min read

18/09/2026










CHMP recommended EU approval of Roche’s Ocrevus for children and adolescents with RMS (Ref)


The EMA’s CHMP recommended approval of Ocrevus® (ocrelizumab; CD20 inhibitor) intravenous infusion for patients aged ≥10 years with relapsing forms of multiple sclerosis (RMS).


  • The recommendation was based on Ph3, OPERETTA 2 study, in which Ocrevus was non-inferior to fingolimod at controlling relapse and superior at reducing brain lesions.


  • A final decision from the European Commission is expected in the near future.












Novartis’ Cosentyx® received a positive CHMP opinion for PMR (Ref)


The EMA’s CHMP adopted a positive opinion recommending marketing authorisation for Cosentyx® (secukinumab; anti-IL-17A) in adult with polymyalgia rheumatica (PMR) who have had an inadequate response to steroids or who experience relapse during steroid taper.


  • The recommendation was supported by Ph3, REPLENISH/ NCT05767034.


  • Final decision from the European Commission is expected within 2 months.













Klygefa recommended for EU approval for gMG (Ref)


The EMA’s CHMP recommended approval for Alexion, AstraZeneca’s Klygefa (gefurulimab; C5 inhibitor) as an add-on to standard therapy for adults with generalised myasthenia gravis (gMG) who are AChR antibody positive.


  • The recommendation was based on Ph3, PREVAIL/ NCT05556096 trial which demonstrated statistically significant and clinically meaningful improvement in Myasthenia Gravis Activities of Daily Living score.


  • Klygefa was generally well-tolerated, and the safety profile was consistent with previous trials of C5 inhibitors in gMG.












Alfasigma’s filgotinib received a positive CHMP opinion for axSpA (Ref)


The EMA’s CHMP issued positive opinion for filgotinib (JAK1 preferential inhibitor) for adults with active non-radiographic or radiographic axial spondyloarthritis (axSpA) who have responded inadequately to conventional therapy.


  • The recommendation was based on Ph3, OLINGUITO/ NCT05785611, where data showed early improvements in the signs and symptoms maintained over 52 weeks.



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