Pharmaceutical Market Europe • July/August 2025 • 10-11
DERMATOLOGY NEWS
The US Food and Drug Administration (FDA) has approved a new presentation of Celltrion’s SteQeyma, an ustekinumab biosimilar referencing Johnson & Johnson’s Stelara, to treat paediatric patients with plaque psoriasis (PsO) or psoriatic arthritis (PsA).
The drug is now authorised as a 45mg/0.5ml solution in a single-dose vial for subcutaneous injection in patients aged six to 17 years who weigh less than 60kg.
It is hoped that the approval will help meet physicians’ clinical needs and support treatment continuity for patients.
The FDA’s decision comes six months after it approved SteQeyma 45mg/0.5ml and 90mg/ml in a single-dose pre-filled syringe for subcutaneous injection, and SteQeyma 130mg/26ml in a single-dose vial for intravenous infusion.
The December authorisation applied to adult and paediatric patients aged six years and older with PsO and PsA, as well as adults with two other inflammatory conditions.
Among the evidence supporting the regulator’s latest approval of SteQeyma were positive results from a phase 3 study in adults with moderate-to-severe PsO, in which Celltrion’s biosimilar and Stelara showed no clinically meaningful differences in terms of safety and efficacy.
Boehringer Ingelheim’s Spevigo (spesolimab) has been recommended by the National Institute for Health and Care Excellence (NICE) to treat generalised pustular psoriasis (GPP) flares.
The health technology assessment agency has recommended that the drug be used on the NHS in England and Wales to treat adults with the rare form of psoriasis, giving patients access to a therapy that targets the interleukin-36 pathway for the first time.
GPP is an unpredictable and severe disease characterised by recurrent flares of pustules covering large areas of the body. These flares can be life-threatening due to the potential for serious complications such as sepsis, heart and kidney failure.
NICE’s decision on the drug was supported by positive results from the phase 2 Effisayil 1 trial, which randomised adults with moderate-to-severe GPP flares to receive a single 900mg intravenous dose of Spevigo or placebo.
The proportion of patients who achieved a Generalised Pustular Psoriasis Physician Global Assessment pustulation sub-score of zero or one (clear or almost clear skin) was higher in the Spevigo arm, with a risk difference of 46%.
Sanofi and Regeneron’s Dupixent (dupilumab) has been granted approval by the US Food and Drug Administration (FDA) to treat bullous pemphigoid (BP) in adults.
The drug is now the only targeted medicine approved in the US to treat the chronic and relapsing skin disease, the partners outlined.
Approximately 27,000 adults in the US are living with BP that is uncontrolled by systemic corticosteroids. The condition mainly affects older adults and is characterised by intense itch, painful blisters and lesions, as well as reddening of the skin.
The FDA’s decision was supported by positive results from the phase 2/3 ADEPT trial, which randomised 106 adults with moderate-to-severe BP to receive Dupixent 300mg or placebo added to standard-of-care oral corticosteroids.
The study met its primary endpoint, with 18.3% of Dupixent-treated patients experiencing sustained disease remission compared to 6.1% of those in the placebo group at 36 weeks.
At the same time point, 38.3% of patients being treated with Dupixent achieved clinically meaningful itch reduction compared to 10.5%, and oral corticosteroid use was lower in the Dupixent group.
UCB has announced positive new three-year data for its inflammatory disease drug Bimzelx (bimekizumab) in adults with active psoriatic arthritis (PsA).
Results from the phase 3 BE OPTIMAL and BE COMPLETE trials and their open-label extension study, BE VITAL, were presented at this year’s European Alliance of Associations for Rheumatology Congress.
Approximately 125 million people worldwide are affected by some form of psoriasis, a chronic inflammatory condition that typically affects the skin, nails and joints. PsA, characterised by skin plaques, swollen toes and fingers, and joint pain and stiffness, affects around 30% of psoriasis patients.
Complete skin clearance, as assessed by a Psoriasis Area and Severity Index score of 100, was maintained to three years by 61.9% of patients who were naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD-naïve) and by 67.5% of patients who were inadequate responders or intolerant to tumour necrosis factor inhibitors (TNFi-IR).
Minimal disease activity was sustained to three years by 52.9% and 48.8% of bDMARD-naïve and TNFi-IR patients, respectively, while 59.5% and 59.1% of bDMARD-naïve and TNFi-IR patients, respectively, achieved elimination of swollen joints at the same time point.
Galderma’s Nemluvio (nemolizumab) has demonstrated sustained and clinically meaningful improvements in the key signs and symptoms of prurigo nodularis, according to results from a long-term extension (LTE) study of the drug.
Data from an interim analysis of the OLYMPIA LTE, presented at this year’s International Congress of Dermatology, showed that more than 90% and 70% of evaluable patients achieved at least a four-point improvement in itch, and were itch free or nearly itch free, respectively, at week 100.
At the same time point, at least 80% of patients in the trial achieved 76% to 100% healed pruriginous lesions, and around 75% experienced clearance or almost-clearance of skin nodules.
The drug was also found to be well tolerated, with no new safety signals identified in the study to date.
Estimated to affect up to 181,000 people in the US, prurigo nodularis is a chronic skin disorder characterised by intense itch and thick skin nodules covering large body areas.
Nemluvio, which was initially developed by Chugai Pharmaceutical, is designed to address the underlying cause of the disorder by inhibiting signalling of the neuroimmune cytokine IL-31.
Nektar Therapeutics has shared positive results from a phase 2b study of investigational rezpegaldesleukin in atopic dermatitis (AD).
The ongoing REZOLVE-AD trial randomised over 390 patients with moderate-to-severe AD to receive one of three doses of the candidate or placebo.
The trial met its primary endpoint, with all doses of rezpegaldesleukin demonstrating significant improvements on the Eczema Area and Severity Score (EASI) compared to placebo at week 16.
The high dose of rezpegaldesleukin achieved a 61% mean improvement in EASI from baseline versus a 31% improvement in the placebo cohort, while the middle and low doses achieved 58% and 53% improvements, respectively.
At the same time point, all three rezpegaldesleukin dose arms achieved statistical significance for the key secondary endpoints of at least a 75% reduction in EASI from baseline, at least a 50% reduction in EASI from baseline and mean percent improvement in Body Surface Area score from baseline.
Patients receiving high and middle doses of the drug also achieved significant improvements in itch, and 25% of those in the high-dose group achieved at least a 90% reduction in EASI from baseline.