Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- Jun 11
- 2 min read
09/06/2026
US FDA approved a new every-eight week maintaince dosing option for Lilly’s lebrikizumab in moderate-to-severe atopic dermatitis (Ref)
Eli lilly announced that the US FDA approved a regimen of one maintenance dose every eight weeks of a single injection (250 mg/2 mL) of EBGLYSS (lebrikizumab-lbkz; an anti- IL-13) for subcutaneous use in adults and children 12 years of age and older who weighing at least 40 kg with moderate-to-severe atopic dermatitis.
The approval was based on longitudinal exposure-response modeling data and was supported by Phase 3 Adjoin long-term trial which evaluated EBGLYSS maintenance dosing every four weeks or every eight weeks over 32 weeks.
No new safety signals were noted in the EBGLYSS safety data in the 32-week ADjoin Q8W extension.
Lilly held exclusive development and commercialization rights for EBGLYSS in US and rest of the world, except in Europe.
Almirall had licenced the rights to develop and commercialize EBGLYSS for dermatology indications, including atopic dermatitis, in Europe.
US FDA accepted Takeda's application for Intravenous vedolizumab in Pediatric UC and CD (Ref)
Takeda announced that the US FDA had accepted for review its supplemental Biologics License Application (sBLA) for intravenous ENTYVIO® (vedolizumab; an anti-α4β7 integrin) for the treatment of moderately to severely active ulcerative colitis (UC) and Crohn’s disease in pediatric patients ages 2 years and older.
The sBLA and the MMA were supported by Phase 3 pediatric trials in patients aged 2 to 17 years: the KEPLER/ NCT04779307 in UC and the WEBB/ NCT04779320 in CD.
The FDA had set a Prescription Drug User Fee Act (PDUFA) goal date in the Q1 2027.
Takeda has also submitted a MAA to the EMA for moderately to severely active UC and CD in pediatric patients ages 2 years and older, and planned to submit applications in additional markets later in 2026.
