Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- Jun 24
- 2 min read
23/06/2026
Sanofi’s Wayrilz approved in Japan to treat immune thrombocytopenia (Ref)
Sanofi announced that the Ministry of Health, Labour and Welfare in Japan had granted marketing and manufacturing authorization to Wayrilz (rilzabrutinib; BTK inhibitor) for the treatment of persistent or chronic immune thrombocytopenia (ITP) in patients who did not respond sufficiently to other treatments or in whom tolerability was considered to be problematic.
The approval was based on the phase 3, LUNA 3/ NCT04562766, in which Wayrilz met the primary and secondary endpoints, showing a positive impact on sustained platelet counts and other symptoms.
The most common adverse reactions (incidence ≥10%) were diarrhea, nausea, headache, abdominal pain, and COVID-19.
Sanofi’s tolebrutinib approved in the EU for secondary progressive multiple sclerosis without relapses (Ref)
Sanofi announced that the European Commission had approved Cenrifki (tolebrutinib; BTK inhibitor) for the treatment of secondary progressive multiple sclerosis (SPMS) without relapses in the last two years.
This approval followed the positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use.
The approval was based on results from the phase 3, HERCULES/ NCT04411641 trial in non-relapsing SPMS (nrSPMS), with supporting data from the GEMINI 1/ NCT04410978 and GEMINI 2/ NCT04410991 studies in in relapsing multiple sclerosis (RMS).
The safety profile of Cenrifki was consistent across the clinical program. The most common adverse events were COVID-19 and upper respiratory tract infections.
Abbive announced EC approval of risankizumab for the treatment of pediatric patients with oderate to severe plaque psoriasis (Ref)
Abbive announced that the European Commission (EC) had approved SKYRIZI® (Risankizumab; IL-23 inhibitor) for the treatment of children and adolescents six years of age and older with moderate to severe plaque psoriasis who are candidates for systemic therapy.
Approval was based on the Phase 3, OptIMMize-1/ NCT04435600 and OptIMMize-2/ NCT04862286 trials which include a new 55 mg pre-filled syringe to support weight-based dosing for patients weighing less than 40 kg.
The safety profile in pediatric patients treated with SKYRIZI was consistent with that observed in adults with moderate to severe plaque psoriasis, with no new safety signals observed.
