This week’s Immunology update highlights regulatory actions, clinical progress, access partnerships, dermatology data, and school safety advocacy.
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💻 Virtual rheumatology access in Missouri [1] [US • 22 Apr 2026]
https://www.prnewswire.com/news-releases/columbia-orthopaedic-group-signs-partnership-with-remission-medical-to-offer-virtual-rheumatology-care-302750651.html
Context: Columbia Orthopaedic Group (Missouri) will offer rheumatology care through Remission Medical, a virtual rheumatology company.
Key point: The partnership aims to reduce wait times and support diagnosis and longitudinal care for new and existing patients.
Implication: May expand screening, initiation, and follow-up at scale.
💊 Rhapsido EC approval for chronic spontaneous urticaria [2] [EU • 27 Apr 2026]
https://www.novartis.com/news/media-releases/novartis-rhapsido-receives-european-commission-approval-first-oral-targeted-treatment-chronic-spontaneous-urticaria
Context: Rhapsido (remibrutinib; Novartis; oral BTK inhibitor) was studied in REMIX 1 and REMIX 2.
Key point: The European Commission approved Rhapsido for adults with chronic spontaneous urticaria inadequately controlled by H1-antihistamines.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Efimosfermin regulatory designations for MASH [3] [US/EU • 27 Apr 2026]
https://www.gsk.com/en-gb/media/press-releases/gsk-s-investigational-liver-therapy-efimosfermin-receives-us-fda-breakthrough-therapy/
Context: Efimosfermin (GSK; once-monthly investigational liver therapy) is in Phase 3 ZENITH-1 and ZENITH-2 for MASH with F2/F3 fibrosis.
Key point: FDA Breakthrough Therapy and EMA PRIME designations were supported by Phase 2 data showing fibrosis improvement and MASH resolution versus placebo.
Implication: May influence prescriber choice and payer reviews pending full data.
🖊️ Saphnelo Pen US approval for SLE [4] [US • 27 Apr 2026]
https://www.astrazeneca.com/media-centre/press-releases/2026/saphnelo-self-administration-approved-in-the-US.html
Context: Saphnelo (anifrolumab; AstraZeneca) is approved as IV infusion in more than 70 countries for moderate to severe SLE.
Key point: FDA approved once-weekly subcutaneous self-administration with the Saphnelo Pen for adults with SLE on standard therapy.
Implication: Could streamline initiation and adherence via remote prescribing and logistics.
🩸 IMAAVY Priority Review in warm autoimmune hemolytic anemia [5] [US • 27 Apr 2026]
https://www.jnj.com/media-center/press-releases/fda-grants-priority-review-for-imaavy-nipocalimab-aahu-as-the-potential-first-approved-treatment-for-people-living-with-warm-autoimmune-hemolytic-anemia-waiha
Context: IMAAVY (nipocalimab-aahu; Johnson & Johnson; FcRn blocker) is under FDA review for warm autoimmune hemolytic anemia.
Key point: FDA granted Priority Review to the sBLA after ENERGY data showed durable hemoglobin response and fatigue improvement versus placebo.
Implication: May influence prescriber choice and payer reviews pending full data.
💇 VDPHL01 oral minoxidil Phase 2/3 data [6] [US • 27 Apr 2026]
https://www.dermatologytimes.com/view/phase-2-3-trial-of-extended-release-oral-minoxidil-shows-robust-hair-growth-outcomes-in-male-pattern-hair-loss
Context: VDPHL01 (Veradermics; extended-release oral minoxidil) was tested in Study 302 Part A in 519 men with androgenetic alopecia.
Key point: The randomized Phase 2/3 trial met both co-primary endpoints at month 6, non-vellus TAHC and AAIRS patient-reported improvement.
Implication: May influence prescriber choice and payer reviews pending full data.
🧴 ORKA-001 psoriasis Phase 2a interim data [7] [US–Canada • 27 Apr 2026]
https://www.dermatologytimes.com/view/orka-001-achieves-complete-skin-clearance-in-nearly-2-3-of-psoriasis-patients-at-week-16
Context: ORKA-001 (Oruka Therapeutics; half-life extended IL-23 monoclonal antibody) was studied in EVERLAST-A across 26 US and Canadian sites.
Key point: Interim Phase 2a data showed PASI 100 in 63.5% of ORKA-001-treated patients at week 16 versus minimal placebo response.
Implication: May influence prescriber choice and payer reviews pending full data.
👶 ZORYVE infant atopic dermatitis sNDA [8] [US • 27 Apr 2026]
https://www.arcutis.com/arcutis-submits-supplemental-new-drug-application-to-the-fda-for-zoryve-roflumilast-cream-0-05-to-expand-indication-for-treatment-of-atopic-dermatitis-to-infants-down-to-3-months/
Context: ZORYVE (roflumilast) cream 0.05% (Arcutis) is already approved for mild to moderate atopic dermatitis in children aged 2–5 years.
Key point: Arcutis submitted an sNDA to expand use to infants aged 3 months to less than 24 months, supported by infant PK and Phase 2 open-label data.
Implication: May influence prescriber choice and payer reviews pending full data.
🏫 EAACI anaphylaxis-safe schools manifesto [9] [Spain • 27 Apr 2026]
https://www.globenewswire.com/news-release/2026/04/27/3281396/0/en/every-minute-counts-eaaci-calls-for-urgent-action-to-make-schools-safe-for-children-at-risk-of-anaphylaxis.html
Context: EAACI, AEPNAA, SEAIC, and SEICAP endorsed a manifesto at the Spanish Congress of Deputies.
Key point: The groups called for school protocols, mandatory staff training, accessible adrenaline auto-injectors, and individualised care plans.
Implication: May expand screening, initiation, and follow-up at scale.
Why it matters
- Access models are moving closer to patients, from virtual rheumatology to school-based anaphylaxis preparedness. [1][9]
- Immunology approvals and reviews are adding more convenient routes or first-in-condition potential. [2][4][5]
- MASH remains a high-unmet-need liver disease, and GSK’s efimosfermin now has expedited regulatory support in the US and EU. [3]
- Dermatology development is active across chronic inflammatory disease, hair loss, and infant eczema. [6][7][8]
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FAQ
What did Columbia Orthopaedic Group and Remission Medical announce?
They announced a partnership to offer virtual rheumatology care to new and existing Columbia Orthopaedic Group patients in Missouri. The stated goal is faster access to diagnosis and therapy when needed. [1]
What is Rhapsido approved for in Europe?
Rhapsido (remibrutinib; Novartis) is approved for adult chronic spontaneous urticaria patients with inadequate response to H1-antihistamine treatment. It is described by Novartis as the first oral targeted CSU treatment approved in Europe. [2]
What regulatory support did efimosfermin receive?
Efimosfermin (GSK) received FDA Breakthrough Therapy Designation and EMA PRIME Designation for MASH. The designations were supported by Phase 2 data in patients with F2/F3 and F4 fibrosis. [3]
What changed for Saphnelo in the US?
FDA approved Saphnelo Pen for once-weekly subcutaneous self-administration in adults with systemic lupus erythematosus on standard therapy. The approval was based on the Phase 3 TULIP-SC trial. [4]
What is the status of IMAAVY in warm autoimmune hemolytic anemia?
FDA granted Priority Review to Johnson & Johnson’s sBLA for IMAAVY (nipocalimab-aahu). J&J said ENERGY showed durable hemoglobin response and fatigue improvement versus placebo. [5]
What infant population is Arcutis seeking for ZORYVE cream?
Arcutis submitted an sNDA for ZORYVE cream 0.05% in mild to moderate atopic dermatitis in infants down to 3 months. The filing includes data from infants aged 3 months to less than 24 months. [8]
Entities / Keywords
Columbia Orthopaedic Group, Remission Medical, virtual rheumatology, Missouri, rheumatic disease
Novartis, Rhapsido, remibrutinib, BTK inhibitor, chronic spontaneous urticaria, CSU, H1-antihistamines
GSK, efimosfermin, MASH, metabolic dysfunction-associated steatohepatitis, FDA Breakthrough Therapy, EMA PRIME, ZENITH-1, ZENITH-2
AstraZeneca, Saphnelo, anifrolumab, Saphnelo Pen, systemic lupus erythematosus, SLE, TULIP-SC
Johnson & Johnson, IMAAVY, nipocalimab-aahu, FcRn, warm autoimmune hemolytic anemia, wAIHA, ENERGY
Veradermics, VDPHL01, extended-release oral minoxidil, androgenetic alopecia, male pattern hair loss, Study 302
Oruka Therapeutics, ORKA-001, IL-23, plaque psoriasis, EVERLAST-A, PASI 100
Arcutis, ZORYVE, roflumilast cream 0.05%, atopic dermatitis, INTEGUMENT-INFANT
EAACI, AEPNAA, SEAIC, SEICAP, anaphylaxis, adrenaline auto-injectors, school safety
References