Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
30/09/2026
Roche’s fenebrutinib received US FDA filing acceptance for RMS and PPMS (Ref)
The US FDA accepted Roche’s NDA for fenebrutinib (BTKi) under Priority Review for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS), supported by Ph3 FENhance 1 and 2 RMS studies and the Ph3 FENtrepid PPMS study.
Fenebrutinib reduced annualized relapse rates by 51% and 58% vs teriflunomide in Ph3 RMS trials while showed a positive trend in delaying disability.
Merck’s tulisokibart met primary and key secondary endpoints in Ph2b HS study (Ref)
Merck’s tulisokibart (anti-TL1A) met the primary endpoint of HiSCR50 at wk 16 in pts in Ph2, MK-7240-012/ NCT06956235 study in pts with moderate-to-severe Hidradenitis Suppurativa (HS), with 72% and 64% of pts achieving HiSCR50 with 480 mg Q2W and Q4W, respectively, vs 35% with placebo.
HiSCR75 was achieved by 41% and 40% of patients with 480 mg Q2W and Q4W, respectively, vs 15% with placebo, with a comparable safety profile.
Results will be presented at EADV'26 congress.
