LEO Pharma’s Anzupgo (delgocitinib) cream has been approved by the European Commission (EC) to treat adults with moderate-to-severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.

The pan-Janus kinase inhibitor is now the first topical treatment specifically indicated for this patient population in the EU.

CHE, an inflammatory skin disease, is defined as hand eczema that lasts for more than three months or relapses at least twice within a year.

The approval follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the late-stage DELTA 1 and DELTA 2 trials, which compared the safety and efficacy of the therapy to vehicle cream.

The primary endpoint, Investigator’s Global Assessment for chronic hand eczema treatment success at week 16, was met in both studies and all secondary endpoints were achieved, including a reduction in itch and pain scores of at least four points.

Data from the 36-week DELTA 3 open-label extension trial, which demonstrated a consistent safety profile and sustained treatment success, also informed the regulator’s decision.

Eli Lilly has announced that the US Food and Drug Administration (FDA) has approved its targeted IL-13 inhibitor Ebglyss (lebrikizumab-lbkz) to treat moderate-to-severe atopic dermatitis (AD).

The drug has been authorised for use in adults and adolescents aged 12 years and older with a body weight of at least 40kg and whose AD is not well controlled despite treatment with topical prescription therapies.

Ebglyss, which works by targeting eczema inflammation throughout the body, can be used with or without topical corticosteroids and is dosed as a single monthly maintenance injection following an initial treatment phase.

The FDA’s decision was supported by results from the late-stage ADvocate1 and ADvocate2 trials evaluating Ebglyss as a monotherapy in adult and adolescents with moderate-to-severe AD, as well as data from the phase 3 ADhere study assessing the drug in combination with topical corticosteroids.

Lilly has exclusive rights for development and commercialisation of Ebglyss in the US and the rest of the world outside Europe, where Almirall has licensed the rights to develop and commercialise the drug for dermatology indications.

Merck & Co – known as MSD outside the US and Canada – has shared positive ten-year results from a late-stage study of its anti-PD-1 therapy Keytruda (pembrolizumab) in melanoma.

The open-label KEYNOTE-006 trial has been evaluating the drug against Bristol Myers Squibb’s Yervoy (ipilimumab) in patients with advanced cases of the skin cancer.

The incidence of melanoma has been rising steadily over the past few decades, with more than 100,640 people expected to be diagnosed with the disease in the US this year.

Keytruda is already authorised to treat certain cases of melanoma, including patients with unresectable or metastatic disease, and those with stages 2B, 2C or 3 disease following complete resection.

The results presented at this year’s European Society for Medical Oncology Congress showed “sustained improved survival outcomes” for patients receiving Keytruda as a single agent compared to Yervoy, Merck said.

The ten-year overall survival (OS) rate for Keytruda was 34% compared to 23.6% for Yervoy. Merck’s drug was also shown to reduce the risk of death by 29%, and more than doubled median OS compared to Yervoy, at 32.7 months versus 15.9 months.

UCB has shared positive two-year results for its inflammatory disease drug Bimzelx (bimekizumab) in moderate-to-severe hidradenitis suppurativa (HS).

Data from the phase 3 BE HEARD I and BE HEARD II trials and their open-label extension, presented at this year’s European Academy of Dermatology and Venereology Congress, showed that the clinically meaningful improvements observed with the drug at one year were maintained over two years.

At week 96, 85.4% of pateints receiving Bimzelx achieved at least a 50% reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count (HiSCR50). HiSCR75 and HiSCR100, were achieved by 77.1% and 44.2% of patients, respectively.

Improvements in disease severity and health-related quality of life, and reductions in draining tunnel count were also maintained over two years.

Affecting approximately 1% of the population in most studied countries, HS is an inflammatory skin disease that causes nodules, abscesses and pus-discharging draining tunnels.

Bimzelx is designed to selectively inhibit two key cytokines driving inflammatory processes and is already approved in the EU to treat HS, plaque psoriasis, psoriatic arthritis and axial spondyloarthritis.

Sanofi and Regeneron’s Dupixent (dupilumab) has demonstrated significant improvements in itch and hives for patients with chronic spontaneous urticaria (CSU), according to late-stage results shared by the companies.

Detailed results from the confirmatory trial will be submitted to the US Food and Drug Administration by the end of the year, after the regulator requested additional data for the therapy in this indication.

Study C of the phase 3 LIBERTY-CUPID programme randomised more than 150 CSU patients aged six years and older to receive Dupixent or placebo as an add-on to standard-of-care antihistamines.

Patients enrolled to the trial remained symptomatic despite antihistamine use and were not previously treated with Novartis and Genentech’s Xolair (omalizumab).

An 8.64-point reduction in itch severity from baseline was observed in the Dupixent group versus a 6.10-point reduction for placebo at 24 weeks.

Dupixent was also shown to be superior in reducing urticaria activity (itch and hive) severity, with a 15.86-point reduction from baseline compared to an 11.21-point reduction with placebo at 24 weeks, and 30% of Dupixent-treated patients reported no urticaria (complete response) compared to 18% of those on placebo.