CHMP, the European Medicines Agency's human-medicines committee, adopted a positive opinion on 17 September 2026 recommending that LEO Pharma's Anzupgo (delgocitinib) cream be approved across the EU for adolescents aged 12 to 17 with moderate-to-severe chronic hand eczema — an indication currently limited to adults. If the European Commission ratifies the opinion, Anzupgo would become the first EU-approved therapy specifically indicated for adolescents with the condition.
A pharmacy from 1908, a foundation since 1984
LEO Pharma has been privately held for most of its history: founded in Copenhagen in 1908, it passed in 1984 into the sole ownership of the LEO Foundation, a nonprofit its then-owner created by donating every share of the company. Nordic Capital bought a minority stake in 2021; the Foundation, through LEO Holding A/S, still holds roughly 80%. The company reported DKK 12.45 billion in 2024 revenue, up 10%, and employs roughly 4,000 people — a large private pharmaceutical company that answers to a foundation's charter rather than public shareholders.
Delgocitinib's road to a second population
- 1908
LEO Pharma founded
Founded in Copenhagen as a pharmacy's chemical-manufacturing arm.
- August 2023
EU marketing application accepted
EMA validated LEO Pharma's application for delgocitinib cream in adults with chronic hand eczema.
- 25 July 2024
First CHMP opinion, adults
CHMP recommended approval for adults with moderate-to-severe chronic hand eczema.
- 19 September 2024
EU approval, adults
European Commission approval made Anzupgo the first EU-wide topical therapy specifically indicated for adult chronic hand eczema.
- 4 February 2025
DELTA TEEN topline results
LEO Pharma announced positive Phase 3 results in adolescents aged 12 to 17.
- 23 July 2025
FDA approval, adults
FDA approved Anzupgo for adults in the United States, under the same brand and formulation.
- 15 December 2025
EU adolescent application submitted
LEO Pharma submitted the label-expansion application to EMA.
- 15 April 2026
US adolescent application accepted
FDA accepted a supplemental application for the same 12-to-17 indication, running in parallel with the EU process.
- 17 September 2026
CHMP recommends adolescent expansion
Positive opinion recommending EU approval for ages 12 to 17, based on DELTA TEEN.
- Expected around November 2026
European Commission decision awaited
On the pace of the adult approval, a decision could come roughly eight weeks after the opinion; not yet announced.
Ninety-eight teenagers, one endpoint
The opinion rests on DELTA TEEN, a Phase 3 trial that randomized 98 adolescents 3:1 to delgocitinib cream or vehicle, applied twice daily for 16 weeks. Sixty-four percent of patients on delgocitinib reached an IGA-CHE score of clear or almost-clear with at least a two-step improvement from baseline, against 29% on vehicle — a 35-percentage-point difference on the trial's primary endpoint, published in The Lancet Child & Adolescent Health. The trial met its primary and all key secondary endpoints, and is distinct from DELTA FORCE, a separate LEO Pharma trial comparing delgocitinib head-to-head against oral alitretinoin in adults.
“Today's positive CHMP opinion marks an important step toward making Anzupgo® available to adolescent patients living with moderate to severe chronic hand eczema in the EU.” Sophie Lamle, Executive Vice President, Development, LEO Pharma — 17 September 2026
Anzupgo's adolescent case in four numbers
Figures from the DELTA TEEN trial publication and the multinational CHECK prevalence study; no adolescent-specific prevalence figure has been published.
Blocking four kinases instead of one target
Delgocitinib is a topical pan-Janus kinase (JAK) inhibitor: it blocks JAK1, JAK2, JAK3 and TYK2 inside skin cells, the four kinases that relay the inflammatory signals driving chronic hand eczema's cracked, thickened, itching skin. Applied as a cream rather than swallowed or injected, it is designed to work locally without the systemic immune suppression associated with oral JAK inhibitors used in other conditions. Anzupgo has carried this same formulation and brand name since its first approval, for adults in the EU in September 2024 and in the US in July 2025.
Three things distinct about a second population
A second population, the same drug
This opinion would extend, not reformulate, an already-approved medicine: Anzupgo has carried the identical brand and formulation in both the EU and US adult markets since 2024 and 2025 respectively.
A trial built for one age group
DELTA TEEN enrolled 98 adolescents specifically, randomizing them 3:1 to delgocitinib or vehicle for 16 weeks — a dedicated pediatric study, not a subgroup analysis carved from the adult trials.
A topical option in a field of systemic tradeoffs
The established alternative for eczema unresponsive to steroids, oral alitretinoin, carries teratogenicity warnings and mandatory pregnancy-prevention measures; delgocitinib is a topical cream, a materially different risk profile for a population that includes adolescent girls.
Where a cream fits among pills and injections
Chronic hand eczema affects roughly 4.7% of adults annually across the six countries studied in the CHECK study, the largest multinational prevalence survey of the condition to date; no adolescent-specific prevalence figure has been published, and this article does not assert one. First-line treatment remains topical corticosteroids; patients who don't respond have historically stepped up to oral alitretinoin. Delgocitinib entered that gap as a topical, non-steroidal, non-teratogenic option for adults in 2024, and this opinion would extend it to adolescents for the first time.
Chronic hand eczema treatment, a decade out
$12.6B → $26.8B
Seven major markets for chronic hand eczema treatment, 2023 to 2034, as forecast by IMARC Group.
Sources: IMARC Group, Chronic Hand Eczema Market Report
Regulatory News outlook
We expect the adolescent segment CHMP just endorsed to add a small but genuine slice of that growth: even a 5% share of the market's forecast expansion between 2023 and 2034 would be worth about $710 million a year by the mid-2030s, split across delgocitinib and whatever rivals follow it into the age group.
How we got here: IMARC Group's forecast implies $14.2 billion of category growth between 2023 and 2034 ($26.8 billion minus $12.6 billion); we apply an illustrative 5% share to approximate the adolescent segment's potential contribution, not a projection of Anzupgo's actual sales.
Delgocitinib against chronic hand eczema's other options
| Product | Mechanism | Formulation | EU/US status |
|---|---|---|---|
| Delgocitinib (Anzupgo, LEO Pharma) | Pan-JAK inhibitor (JAK1/2/3, TYK2) | Topical cream | Approved, adults; EU adolescent expansion recommended Sept. 2026 |
| Alitretinoin (Toctino) | Oral retinoid | Oral capsule | EU-approved for severe CHE; not FDA-approved |
| Topical corticosteroids | Broad anti-inflammatory/immunosuppressive | Topical cream or ointment | First-line standard of care, both regions |
| Topical ruxolitinib | JAK1/2 inhibitor | Topical cream | Investigational for hand eczema; not approved for this use |
From each company's own labelling and published trial data; not a clinical comparison.
What the adult approval's 56-day gap predicts
What is not yet decided is the European Commission's ratification. In the adult indication, the Commission followed CHMP's July 2024 opinion with formal EU approval 56 days later, in September 2024 — if the adolescent expansion moves at a similar pace, a decision could come around mid-November 2026, though the Commission's own rules allow up to 67 days and nothing is confirmed until it acts. A parallel US process is already under way: FDA accepted a supplemental application for the same 12-to-17 indication in April 2026, with no decision date yet public.
Sources & further reading
- LEO Pharma, “LEO Pharma Receives Positive CHMP Opinion Recommending Anzupgo (delgocitinib) Cream for Adolescents with Moderate to Severe Chronic Hand Eczema in the EU,” press release, 17 September 2026. leo-pharma.com
- “Delgocitinib cream for adolescents with moderate to severe chronic hand eczema (DELTA TEEN): a multicentre, double-blind, phase 3 randomised controlled trial,” The Lancet Child & Adolescent Health. pubmed.ncbi.nlm.nih.gov
- “High prevalence of chronic hand eczema in Europe and Canada,” British Journal of Dermatology (the CHECK study). pubmed.ncbi.nlm.nih.gov
- LEO Pharma, media center — news releases. leo-pharma.com
- Anzupgo (delgocitinib), healthcare-professional product site. anzupgohcp.com
- IMARC Group, Chronic Hand Eczema Market Report. imarcgroup.com
Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.
Frequently asked questions
What did CHMP recommend for Anzupgo?
On 17 September 2026, CHMP adopted a positive opinion recommending that Anzupgo (delgocitinib) cream be approved across the EU for adolescents aged 12 to 17 with moderate-to-severe chronic hand eczema, extending an indication currently limited to adults. The European Commission still has to ratify the opinion before it becomes a binding EU approval.
What trial supports this opinion?
DELTA TEEN, a Phase 3 trial that randomized 98 adolescents 3:1 to delgocitinib cream or vehicle for 16 weeks. 64% of patients on delgocitinib reached clear or almost-clear skin, against 29% on vehicle, meeting the trial's primary and all key secondary endpoints.
Is Anzupgo already approved for anyone?
Yes. The European Commission approved it for adults in September 2024, and FDA approved it for adults in the US in July 2025, under the same brand name and formulation in both regions.
When will the EU adolescent approval be final?
Not yet announced. The European Commission has up to 67 days to act on a CHMP opinion; in the adult indication, it took 56 days. On that pace, a decision could arrive around mid-November 2026, though this is Regulatory News's estimate, not a confirmed date.
