Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- 2 days ago
- 2 min read
Updated: 2 days ago
20/07/2026
Almirall announced EMA acceptance of the pediatric filing for Ebglyss® in atopic dermatitis
AbelZeta received EMA PRIME designation for C-CAR168 in LN and SLE (Ref)
AbelZeta Pharma announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had granted PRIority MEdicines (PRIME) designation to C-CAR168 (an autologous anti-CD20/BCMA CAR-T), for the treatment of refractory Systemic Lupus Erythematosus (SLE), with or without Lupus Nephritis (LN).
The designation reflected the significant unmet medical need in refractory SLE and LN.
The designation provided enhanced regulatory support from the EMA including early dialogue and scientific advice, intended to optimize development and potentially accelerate evaluation of C-CAR168.
C-CAR168 had previously received FDA Regenerative Medicine Advanced Therapy (RMAT) designation in 2025 for the treatment of refractory SLE, including LN.
LAPIX Therapeutics completed patient enrollment in the RA arm of the ongoing LPX-TI641 clinical trial (Ref)
LAPIX Therapeutics announced the completion of enrollment in the rheumatoid arthritis (RA) arm of its ongoing clinical study evaluating LPX-TI641 (oral TIM 3/4 agonist).
The RA arm of the study successfully enrolled all 44 planned subjects across two treatment cohorts.
24 subjects are receiving LPX-TI641 at a dose of 300 mg over a three-month treatment period, while 20 subjects were enrolled in a 150 mg cohort receiving treatment for 28 days.
The ongoing study was designed to evaluate the safety, tolerability, and exploratory measures of biological and clinical activity of LPX-TI641 across multiple inflammatory disease indication.
Almirall announced EMA acceptance of the pediatric filing for Ebglyss® in atopic dermatitis (Ref)
Almirall announced that the European Medicines Agency (EMA) had accepted the submission of the extension of the Marketing Authorisation Application of Ebglyss® (lebrikizumab; anti-IL-13) for the treatment of children and adolescents aged 6 months to <18 years and weighing <40 kg with moderate-to-severe atopic dermatitis (AD).
The application was supported by interim results from the ADorable-1pivotal study the and ADorable-2 long-term extension.
ADorable-1 study met both co-primary and key secondary endpoints demonstrating meaningful improvements in skin clearance, disease severity, itch and quality of life.
The safety profile was consistent with the established safety profile of lebrikizumab approved in Europe for adult and adolescent patients 12 years and older, with no new safety signals observed.
Almirall held the rights to development and commercialization lebrikizumab for dermatology indications including AD, in Europe, while Eli Lilly retains rights outside Europe.
