Pharmaceutical Market Europe • January 2025 • 10-11
DERMATOLOGY NEWS
FDA approves Organon’s Vtama to treat atopic dermatitis
The US Food and Drug Administration (FDA) has approved Organon’s Vtama (tapinarof) cream, 1% to treat atopic dermatitis (AD) in adults and children aged as young as two years.
The approval comes less than two months after Organon completed its acquisition of Dermavant Sciences for approximately $1.2bn, giving it access to the non-steroidal topical therapy.
More than 26 million people in the US are affected by AD, and up to 10% of adults and 20% of children globally.
Vtama is an aryl hydrocarbon receptor agonist that is already approved in the US to treat adults with plaque psoriasis.
The FDA’s decision on the therapy was based on results from the identically designed phase 3 ADORING 1 and 2 trials, in which 45.4% and 46.4% of patients, respectively, achieved clear or almost clear skin and a minimum two-grade improvement from baseline to week eight on the validated investigator global assessment for AD.
Also supporting the approval was data from the long-term extension ADORING 3 study, in which the majority of patients entered with or achieved complete disease clearance at least once in the 48-week open-label period.
CHMP recommends Galderma’s nemolizumab for two skin diseases
The European Medicines Agency’s human medicines committee has recommended Galderma’s nemolizumab to treat atopic dermatitis (AD) and prurigo nodularis (PN) in patients with moderate-to-severe cases of the skin diseases.
The Committee for Medicinal Products for Human Use (CHMP) has recommended that nemolizumab, initially developed by Chugai Pharmaceutical, be used subcutaneously to treat AD patients aged 12 years and older, and in adults with PN. Those eligible for the drug must also be candidates for systemic therapy.
The CHMP’s recommendation in AD was based on results from the phase 3 ARCADIA 1 and 2 trials, in which nemolizumab plus background topical corticosteroids (TCS) showed statistically significant improvements in the co-primary and key secondary endpoints compared to placebo plus TCS after 16 weeks, with significant itch relief observed from week one.
The committee’s decision in PN was supported by data from the late-stage OLYMPIA 1 and 2 trials, which met both their primary and key secondary endpoints, indicating that treatment with nemolizumab resulted in significant and clinically meaningful improvements in itch and skin nodules at week 16, with reductions in itch observed from week four.
J&J expands atopic dermatitis pipeline with Kaken deal
Johnson & Johnson (J&J) has announced that it will be gaining exclusive rights to Kaken Pharmaceutical’s STAT6 programme for autoimmune and allergic diseases, including atopic dermatitis (AD).
The agreement gives J&J a global licence to develop, manufacture and commercialise the programme. This includes Kanken’s lead oral candidate KP-723, which is expected to enter phase 1 clinical development for AD this year.
Kaken will retain the commercialisation rights to the programme in Japan, where J&J will have an option to enter into a co-promotion agreement.
Though J&J did not disclose financial details of the deal, the company said that Kaken will be eligible to receive an equity investment separately from its venture capital organisation, J&J Innovation.
AD affects more than 9.6 million children and 16.5 million adults in the US, and is characterised by an overactive immune system that causes damage to the skin barrier.
STAT6 is a key nodal transcription factor that selectively mediates downstream signaling of interleukin-4 and interleukin-13, which have been shown to play a central role in type 2 inflammatory diseases.
BMS shares phase 3 results for Sotyktu in psoriatic arthritis
Bristol Myers Squibb (BMS) has shared positive top-line results from two late-stage studies of its oral TYK2 inhibitor Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA).
The phase 3 POETYK PsA-1 trial evaluated the drug in patients who were not previously treated with a biologic disease-modifying antirheumatic drug (bDMARD naïve), while POETYK PsA-2 enrolled those who were bDMARD naïve or had previously received TNF alpha inhibitor treatment.
More than eight million people in the US are living with psoriasis, an immune-mediated disease that causes inflammation in the body, and up to 30% will develop PsA, which is characterised by joint pain, stiffness and swelling.
Both trials met their primary endpoint, with a significantly greater proportion of Sotyktu-treated patients achieving at least a 20% improvement in the signs and symptoms of the disease compared to placebo after 16 weeks of treatment.
Important secondary endpoints across PsA disease activity at week 16 were also met in both trials, BMS said, adding that the overall safety profile of Sotyktu with the established safety profile of the drug.
Checkpoint’s Unloxcyt approved by FDA for advanced skin cancer
Checkpoint Therapeutics’ Unloxcyt (cosibelimab-ipdl) has been approved by the US Food and Drug Administration (FDA) to treat cutaneous squamous cell carcinoma (CSCC) in adults.
Patients eligible for the drug will have metastatic CSCC or locally advanced CSCC and will not be candidates for curative surgery or curative radiation.
CSCC is the second most common type of skin cancer in the US, with an estimated annual incidence of approximately 1.8 million cases. While most patients have localised tumours amenable to curative resection, approximately 40,000 people experience advanced disease every year.
The US regulator’s decision, which makes Unloxcyt the first and only PD-L1 blocking antibody to receive FDA marketing approval for this indication, was based on results from the open-label trial Study CK-301-101.
Patients with metastatic CSCC achieved an objective response rate (ORR) of 47%, while ORR was 48% for those with locally advanced disease.
Median duration of response was not reached in the metastatic CSCC group, and was 17.7 months in patients with locally advanced CSCC.
The recommended dose of the drug is 1,200mg given as a one-hour intravenous infusion every three weeks.
Celltrion’s SteQeyma granted FDA approval for inflammatory diseases
Celltrion’s SteQeyma (ustekinumab-stba), a biosimilar referencing Johnson & Johnson’s Stelara (ustekinumab), has been approved by the US Food and Drug Administration (FDA) for multiple inflammatory diseases, including plaque psoriasis.
The IL-12 and IL-23 antagonist has been authorised for use as a subcutaneous injection or intravenous infusion in adult and paediatric patients aged six years and older with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and adult and paediatric patients aged six years and older with active psoriatic arthritis.
The drug has also been approved to treat Crohn’s disease and ulcerative colitis in adults with moderately to severely active disease.
Biosimilars, according to the FDA, are biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved reference product.
The US regulator’s decision on SteQeyma, formerly known as CT-P43, was based on the totality of evidence, including data from a phase 3 study in adults with moderate-to-severe plaque psoriasis.
The clinical results showed that SteQeyma and its reference product are highly similar and have no clinically meaningful differences in terms of safety and efficacy.
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