Pharmaceutical Market Europe • September 2025 • 10-11
DERMATOLOGY NEWS
LEO’s Anzupgo granted FDA approval for chronic hand eczema
LEO Pharma’s Anzupgo (delgocitinib) cream has been approved by the US Food and Drug Administration (FDA) to treat adults with moderate-to-severe chronic hand eczema (CHE).
Patients eligible for the steroid-free pan-Janus kinase (JAK) inhibitor, which is now the first treatment approved by the regulator specifically for this population, will have had an inadequate response to, or not be advised, topical corticosteroids.
CHE, defined as hand eczema that lasts for more than three months or relapses at least twice within a year, is characterised by fluctuating itch and pain.
LEO’s Anzupgo cream is designed to inhibit the activation of the JAK-STAT signalling pathway, suppressing the various inflammatory responses that play a key role in the onset and subsequent flares of CHE.
The therapy met the primary endpoint, Investigator’s Global Assessment for CHE treatment success at week 16, in the phase 3 DELTA 1 and DELTA 2 trials, as well as all secondary endpoints, including a reduction in itch and pain scores of at least four points, as measured by the Hand Eczema Symptom Diary from baseline to week 16.
Global licensing deal signed for Boehringer’s drug Spevigo
Boehringer Ingelheim and LEO Pharma have entered into a partnership to commercialise and advance the development of Boehringer’s generalised pustular psoriasis (GPP) drug Spevigo (spesolimab).
The exclusive global licensing and transfer agreement, expected to close later this year, will see LEO take on responsibility for the commercialisation and further development of Spevigo, using its global commercial platform to raise disease awareness and secure access for GPP patients.
In exchange, Boehringer is set to receive €90m upfront, alongside undisclosed milestone payments and tiered royalties.
GPP is a rare and unpredictable skin condition characterised by recurrent flares of pustules covering large areas of the body.
Spevigo is a selective antibody that blocks the activation of the interleukin-36 (IL-36) receptor, a signalling pathway within the immune system shown to be involved in the pathogenesis of several auto-inflammatory diseases.
It is the first approved treatment for GPP flares that specifically targets the IL-36 pathway and is currently available in more than 40 countries.
The alliance extends beyond GPP, with an opportunity to evaluate the drug in additional skin conditions in which IL-36 is implicated.
Lilly/Almirall’s Ebglyss shows promise in AD patients with darker skin tones
Eli Lilly and Almirall’s Ebglyss (lebrikizumab) has been shown to significantly improve the signs and symptoms of atopic dermatitis (AD) in patients with darker skin tones, according to phase 3b results published in the American Journal of Clinical Dermatology.
The open-label ADmirable trial, funded by Lilly, evaluated Ebglyss as a first-line biologic following topical prescription therapies in 90 adult and adolescent patients aged 12 years and older with moderate-to-severe AD and skin of colour, as measured by the Fitzpatrick scale.
AD often presents differently in patients with darker skin tones, who are more likely to experience hardened skin lesions, hyperpigmentation and severe skin dryness compared to those with lighter skin tones.
Patients in ADmirable, the first Ebglyss phase 3b trial to exclusively investigate adult and adolescent patients with AD and skin of colour, saw improvements at week 24, with response rates increasing between week 16 and week 24.
Results showed that 78% of Ebglyss-treated patients experienced at least a 75% improvement in disease extent and severity and, among those who responded to treatment at week 16, 63% achieved at least a 90% improvement.
AbbVie shares phase 3 results for Rinvoq in alopecia areata
AbbVie has shared promising top-line results from a late-stage study of its JAK inhibitor Rinvoq (upadacitinib) in severe alopecia areata (AA).
Study two of the phase 3 UP-AA clinical programme has been evaluating once-daily 15mg and 30mg doses of the drug in adult and adolescent patients with a mean approximately 16% scalp hair coverage.
Both doses met the primary endpoint, with 44.6% and 54.3% of patients receiving Rinvoq 15mg and 30mg, respectively, reaching 80% or more scalp hair coverage at week 24, compared to 3.4% of patients randomised to receive placebo.
Among Rinvoq-treated patients, 36% of those in the 15mg cohort and 47.1% in the 30mg group reached 90% or more scalp hair coverage, compared to 1.4% of patients receiving placebo at week 24.
Other key secondary endpoints, including improvements in eyebrows and eyelashes, as well as the percentage of patients with complete scalp hair coverage at week 24, were met with both doses of Rinvoq.
Results from study one of the phase 3 UP-AA clinical programme are also expected in the third quarter of 2025.
FDA grants fast track designation to Nektar’s rezpegaldesleukin
The US Food and Drug Administration (FDA) has granted fast track designation to Nektar Therapeutics’ rezpegaldesleukin as a treatment for alopecia areata (AA).
The regulator’s decision specifically applies to adult and paediatric patients aged 12 years and older who weigh at least 40 kilograms and are living with severe-to-very severe cases of the autoimmune disease.
Approximately 700,000 people in the US currently have some form of AA, which occurs when a patient’s own immune system attacks hair follicles, resulting in varying degrees of hair loss.
Rezpegaldesleukin is designed to target the interleukin-2 receptor complex in the body, stimulating the proliferation of inhibitory immune cells called Tregs and potentially bringing the immune system back into balance.
The phase 2b REZOLVE-AA trial is currently evaluating the drug in patients with severe-to-very severe AA who have at least 50% scalp involvement and have not previously been treated with a JAK inhibitor or other biologic.
The primary efficacy endpoint of the study will evaluate the mean per cent change in the Severity of Alopecia Tool score at the end of the 36-week induction period.
Apogee’s atopic dermatitis candidate shows promise
Apogee Therapeutics has shared positive 16-week results from a mid-stage study of its investigational anti-IL-13 antibody in atopic dermatitis (AD).
The phase 2 APEX trial has been evaluating the candidate, APG777, in patients with moderate-to-severe cases of the inflammatory skin condition.
Part A, in which patients received an induction regimen dosing of 720mg at weeks zero and two followed by 360mg at weeks four and 12, met all primary and key secondary endpoints and exceeded the trial’s objectives.
APG777 demonstrated significantly greater least squares mean per cent change from baseline at week 16, with an Eczema Area Severity Index (EASI) reduction of 71% compared to 33.8% for placebo.
Among APG777-treated patients, 66.9% experienced at least a 75% improvement in their EASI score, compared to 24.6% of those on placebo.
Additional key secondaries were “in line with standard of care”, Apogee said, including 33.9% of patients in the APG777 cohort achieving at least a 90% improvement in their EASI score versus 14.7% on placebo.
APG777 also led to a “rapid onset of itch relief” and achieved statistically significant reductions by week one.
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