Immunology Today—March 4, 2026

LucidQuest

2 hours ago

This week’s Immunology update covers key regulatory actions, clinical trial progress and topline data, and selected partnership and real-world evidence initiatives across immune-mediated conditions.

In Today’s Newsletter

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🫁 Dupixent approved in AFRS (Sanofi, Regeneron) [1] [US • 24 Feb 2026]

https://www.sanofi.com/en/media-room/press-releases/2026/2026-02-24-14-30-00-3243732
Context: LIBERTY-AFRS-AIMS (Phase 3; NCT04684524), adults and children aged 6+, history of sino-nasal surgery (n=62).
Key point: FDA approved Dupixent (dupilumab) for AFRS in patients aged 6+ with prior surgery, Sanofi and Regeneron stated efficacy vs placebo on CT opacification and reduced systemic steroid use and/or surgery.
Implication: May influence prescriber choice and payer reviews pending full data.

🩸 IMAAVY sBLA filed for wAIHA (Johnson & Johnson) [3] [US • 24 Feb 2026]

https://www.jnj.com/media-center/press-releases/johnson-johnson-seeks-fda-approval-of-imaavy-nipocalimab-aahu-as-the-first-ever-fda-approved-treatment-for-warm-autoimmune-hemolytic-anemia-waiha
Context: ENERGY (Phase 2/3; NCT04119050), multicenter, randomized, double-blind, placebo-controlled in adults with wAIHA.
Key point: J&J submitted an FDA sBLA for IMAAVY (nipocalimab-aahu; FcRn blocker) in wAIHA, citing ENERGY results on a durable hemoglobin response (definition provided in source).
Implication: May influence prescriber choice and payer reviews pending full data.

🐶 NUMELVI FDA approval for pruritus in canine allergic dermatitis (Merck Animal Health) [2] [US • 25 Feb 2026]

https://www.merck.com/news/fda-approves-numelvi-atinvicitinib-tablets-for-dogs-from-merck-animal-health-the-first-and-only-second-generation-janus-kinase-jak-inhibitor-for-the-control-of-pruritus-associat/
Context: Indication is dogs 6 months of age and older (availability expected spring 2026, per Merck).
Key point: FDA approved NUMELVI (atinvicitinib tablets), described by Merck as the first and only second-generation JAK inhibitor for control of pruritus associated with allergic dermatitis in dogs.
Implication: May influence prescriber choice and payer reviews pending full data.

🤝 Boehringer Ingelheim licenses Sitryx preclinical oral immune program [4] [26 Feb 2026]

https://www.boehringer-ingelheim.com/science-innovation/human-health-innovation/boehringer-gains-exclusive-license-novel-immune-therapies
Context: Preclinical small-molecule program, described as “precision immunometabolic,” across autoimmune and inflammatory indications (candidate specifics not provided).
Key point: Boehringer Ingelheim acquired an exclusive global license to Sitryx Therapeutics’ preclinical small-molecule inhibitor program, with upfront and milestones stated as totaling over US$500 million plus tiered royalties.
Implication: Signals pipeline investment and modality expansion.

🧴 Dupixent recommended for EU approval in pediatric CSU (Sanofi, Regeneron) [6] [EU • 27 Feb 2026]

https://www.sanofi.com/en/media-room/press-releases/2026/2026-02-27-12-03-24-3246438
Context: CHMP positive opinion for children aged 2–11 with moderate-to-severe CSU, inadequate response to H1 antihistamines, anti-IgE naïve (per Sanofi).
Key point: CHMP adopted a positive opinion recommending Dupixent (dupilumab) approval in the EU for CSU in children aged 2–11 (final EC decision pending).
Implication: May influence prescriber choice and payer reviews pending full data.

🧑‍🦲 Olumiant recommended for expanded EU use in adolescents with severe alopecia areata (Lilly, Incyte) [7] [EU • 27 Feb 2026]

https://investor.lilly.com/news-releases/news-release-details/lillys-olumiant-baricitinib-recommended-chmp-approval-expanded
Context: BRAVE-AA-PEDS (Phase 3), 36-week data in ages 12 to <18, once-daily oral baricitinib vs placebo (per Lilly).
Key point: CHMP issued a positive opinion supporting Olumiant (baricitinib) for adolescents with severe alopecia areata, with Lilly citing scalp hair coverage outcomes at 36 weeks.
Implication: May influence prescriber choice and payer reviews pending full data.

💉 Obagi–Schweiger ALOHA collaboration for RWE on saypha MagIQ (Waldencast, Obagi Medical, Schweiger Dermatology) [8] [US • 27 Feb 2026]

https://www.manilatimes.net/2026/02/27/tmt-newswire/globenewswire/obagi-medical-and-schweiger-dermatology-announce-collaboration-in-the-aloha-program-to-drive-real-world-evidence-for-obagi-saypha-magiq/2289972
Context: ALOHA includes a Phase 4 clinical study at a Schweiger site and a broader real-world evaluation program (start expected early 2026, per announcement).
Key point: Obagi Medical and Schweiger Dermatology announced a collaboration to generate real-world evidence for Obagi saypha MagIQ (developed by Croma-Pharma, per source).
Implication: Could inform practice and payer discussions, interpretation depends on study design and confounding control.

🇯🇵 Rilzabrutinib gets orphan drug designation in Japan for IgG4-RD (Sanofi) [5] [Japan • 02 Mar 2026]

https://www.sanofi.com/en/media-room/press-releases/2026/2026-03-02-06-00-00-3247008
Context: Designation based on Phase 2 data (NCT04520451), Phase 3 RILIEF ongoing (NCT07190196), per Sanofi.
Key point: Japan’s MHLW granted orphan drug designation to rilzabrutinib (oral BTK inhibitor) for IgG4-related disease.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 SKYRIZI positive Phase 3 AFFIRM topline for SC induction in Crohn’s disease (AbbVie) [9] [US • 02 Mar 2026]

https://news.abbvie.com/2026-03-02-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-AFFIRM-Study-Evaluating-SKYRIZI-R-Risankizumab-Subcutaneous-Induction-in-Patients-with-Crohns-Disease
Context: AFFIRM (Phase 3), randomized, placebo-controlled, double-blind, adults with moderately to severely active Crohn’s disease (N=289), predominantly prior advanced-therapy failure (65%), per AbbVie.
Key point: AbbVie reported risankizumab (SKYRIZI) SC induction met co-primary endpoints at week 12 (CDAI clinical remission and endoscopic response) vs placebo, with a safety profile consistent with known Crohn’s experience.
Implication: May influence prescriber choice and payer reviews pending full data.

Why it matters

Multiple readouts and regulatory steps reinforce FcRn, IL-4/IL-13, JAK, BTK, and IL-23 pathways as high-velocity immunology platforms this week. [1–3,5–7,9]
Pediatric expansion is a theme, with Dupixent and Olumiant moving into younger populations via FDA approval or EU CHMP opinions. [1,6,7]
AbbVie’s SC induction positioning for SKYRIZI targets convenience and care-pathway flexibility if regulators and guidelines align. [9]
Business development remains active, with Boehringer adding preclinical immunometabolic small molecules via licensing. [4]

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FAQ

What exactly did the FDA approve Dupixent for in AFRS, and who is eligible?

Sanofi and Regeneron say FDA approved Dupixent (dupilumab) for allergic fungal rhinosinusitis in adults and children aged 6+ who have a history of sino-nasal surgery. [1]

What is Johnson & Johnson asking the FDA to do for IMAAVY in wAIHA?

J&J submitted a supplemental BLA seeking approval of IMAAVY (nipocalimab-aahu) for warm autoimmune hemolytic anemia, supported by the Phase 2/3 ENERGY study (full results pending). [3]

How did AbbVie describe SKYRIZI’s Phase 3 AFFIRM results?

AbbVie reported positive topline results for SC induction in Crohn’s disease, including superiority on week 12 co-primary endpoints (CDAI remission and endoscopic response) vs placebo. [9]

What does a CHMP positive opinion mean for Dupixent in pediatric CSU?

Sanofi says CHMP recommended EU approval for Dupixent in children aged 2–11 with moderate-to-severe CSU inadequately controlled by H1 antihistamines, final European Commission decision is pending. [6]

What population is covered in the EU CHMP opinion for Olumiant in alopecia areata?

Lilly and Incyte reported CHMP supported Olumiant (baricitinib) for adolescents (ages 12 to <18) with severe alopecia areata, based on Phase 3 BRAVE-AA-PEDS data. [7]

What is the significance of Japan’s orphan designation for rilzabrutinib?

Sanofi reported Japan’s MHLW granted orphan drug designation to rilzabrutinib for IgG4-related disease, citing prior Phase 2 data and an ongoing Phase 3 program. [5]

Entities / Keywords

Dupixent (dupilumab), Sanofi, Regeneron, allergic fungal rhinosinusitis (AFRS), chronic rhinosinusitis with nasal polyps (CRSwNP), type 2 inflammation, LIBERTY-AFRS-AIMS, NCT04684524
IMAAVY (nipocalimab-aahu), Johnson & Johnson, FcRn, warm autoimmune hemolytic anemia (wAIHA), ENERGY, NCT04119050
NUMELVI (atinvicitinib), Merck Animal Health, MSD Animal Health, canine allergic dermatitis, pruritus, JAK1
Boehringer Ingelheim, Sitryx Therapeutics, immunometabolism, preclinical small molecule, licensing deal
Dupixent, chronic spontaneous urticaria (CSU), H1 antihistamines, anti-IgE, CHMP, EMA
Olumiant (baricitinib), Eli Lilly, Incyte, alopecia areata (AA), BRAVE-AA-PEDS, JAK inhibitor
Obagi Medical, Waldencast, Schweiger Dermatology, ALOHA program, real-world evidence (RWE), saypha MagIQ, Croma-Pharma
Rilzabrutinib, Sanofi, BTK inhibitor, IgG4-related disease (IgG4-RD), MHLW Japan, orphan drug designation, RILIEF, NCT07190196
SKYRIZI (risankizumab), AbbVie, Crohn’s disease, AFFIRM, subcutaneous induction, CDAI, SES-CD