April 2026 • PharmaTimes Magazine • 9

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Lebrikizumab shows strong results for children with atopic dermatitis

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Almirall has reported positive top-line results from its phase 3 ADorable-1 trial, which evaluated lebrikizumab in children and adolescents aged six months to under 18 years with moderate-to-severe atopic dermatitis.

The company said the treatment met both co-primary and key secondary endpoints, with results showing notable improvements in skin clearance, disease severity, itch and quality of life at week 16. According to the data, 63% of paediatric patients achieved meaningful skin improvement and 44% reached clear or almost clear skin.

Dr Karl Ziegelbauer, Chief Scientific Officer at Almirall, said: “At Almirall, we are committed to advancing skin science through a holistic approach to disease management, recognising the profound effect skin conditions have on people’s lives.

“We are excited about the positive, top-line results from the phase 3 ADorable-1 trial and the meaningful impact they could have on children and adolescents and their life trajectories.”

Prof Weidinger, Department of Dermatology, Allergology and Venerology at University Hospital Schleswig-Holstein in Kiel, Germany, explained: “Children with atopic dermatitis still face considerable unmet needs, with persistent symptoms, limited treatment options, and a disease burden that grows with severity.

“There is a need for advanced treatment solutions, considering the specific challenges of younger patients and their families.”


MHRA approves new treatment for severe alopecia areata

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The MHRA has approved deuruxolitinib, marketed as Leqselvi, for the treatment of severe alopecia areata in adults, offering a new therapeutic option for people living with the autoimmune condition.

Alopecia areata occurs when the immune system attacks hair follicles, triggering inflammation that leads to hair loss on the scalp, face or other parts of the body.

Deuruxolitinib works by reducing the activity of JAK1, JAK2 and TYK2 relative to JAK3 kinases, enzymes involved in the inflammatory process at the hair follicle. By dampening this inflammation, the medicine can support hair regrowth.

Julian Beach, MHRA Executive Director, Healthcare Quality and Access, said: “This approval gives adults with alopecia areata another potential treatment option to help manage their condition. As with any medicine, the MHRA will keep the safety and effectiveness of deuruxolitinib under close review.”

Leqselvi is available only on prescription. The recommended dose is an 8 mg tablet taken twice daily.

The approval is based on two pivotal clinical trials involving 1223 adults who had lost at least 50 percent of their hair for more than six months. Participants received either Leqselvi 8 mg, deuruxolitinib 12 mg or a placebo twice daily for 24 weeks.

Those treated with Leqselvi achieved higher scores on a standard measure of scalp hair coverage compared with placebo.


HOT & NOT

Astellas Pharma has announced that the National Institute for Health and Care Excellence has issued Final Draft Guidance recommending fezolinetant 45 mg once daily for treating moderate to severe vasomotor symptoms associated with menopause when hormone replacement therapy is unsuitable.

The decision means the treatment will be made available through the NHS, offering a new non-hormonal option for people experiencing disruptive hot flushes and night-sweats.


AlzeCure Pharma has announced that the European Medicines Agency has granted orphan drug status to ACD440, its clinical-stage pain treatment being developed for erythromelalgia.

The company, which focuses on diseases affecting the nervous system including Alzheimer’s disease and pain, said the designation strengthens the prospects for advancing ACD440 as a potential therapy for patients with this rare and debilitating condition.


Aplagon has dosed the first patient in its phase 2a HEALING clinical trial evaluating APAC, a first-in-class treatment for thrombo-inflammatory diseases, in people with peripheral arterial occlusive disease and chronic limb threatening ischemia.

The study, taking place in Finland, will enrol up to 42 patients across four cohorts and will assess the safety and preliminary efficacy of APAC delivered intravenously. It will also examine the therapy’s impact on thrombo-inflammatory biomarkers in patients with and without revascularisation.


Elevara Medicines has dosed the first patient in its phase 2b START-SYNERGY trial, marking a key step in the development of ELV001, an oral CDK4/6 inhibitor being studied for rheumatoid arthritis in patients who do not respond sufficiently to methotrexate and TNF inhibitors.

The trial builds on earlier studies showing ELV001 was well tolerated and demonstrated early signs of clinical activity.


Responding to the 2025 NHS Staff Survey, Rory Deighton from the NHS Confederation, said: “NHS staff work tirelessly to care for patients and have a right to feel supported, valued and respected at work. It is completely unacceptable that so many colleagues have been physically attacked and subjected to unwanted sexual behaviour in the line of duty.

“There are some small improvements in this year’s staff survey results but most indicators are broadly similar to last year.”


On measles outbreaks, Dr Amit Aggarwal, from the ABPI, said: “Measles outbreaks are a serious concern and underline the importance of maintaining high vaccination coverage to protect individuals and communities.

“Vaccination rates have been declining for a number of years, but we believe the NHS vaccination strategy and the NHS 10-Year Plan have the right approaches to address this, with measures such as vaccination catch-ups, and an expanded role for health visitors.”