Pharmaceutical Market Europe • March 2026 • 11

DERMATOLOGY NEWS

Incyte’s Opzelura approved by NICE as NHS vitiligo treatment

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Incyte Biosciences UK has received NICE approval for eligible NHS patients with non-segmental vitiligo to be reimbursed for Opzelura (ruxolitinib) cream 15mg/g.

This decision follows the publication of the Final Draft Guidance for the topical treatment of adults and adolescents 12 years and older with non-segmental vitiligo with facial involvement.

Ruxolitinib cream, a topical formulation of a Janus kinase 1/2 inhibitor, is the first and only approved treatment in England to offer eligible patients with vitiligo support for re-pigmentation.

Vitiligo is a chronic autoimmune condition in which areas of skin depigment or lose their colour due to the progressive destruction of pigment-producing cells known as melanocytes.

Around one in 100 people in the UK develop vitiligo with approximately eight in ten of those suffering with non-segmental vitiligo, where both sides of the body are affected by symmetrical white patches.

Anyone can develop vitiligo, but it appears more visually prominent in those with darker skin. It is also known to have a large psychosocial impact, which can negatively impact the quality of life of people living with the condition.


Moderna and Merck announce follow-up data from melanoma study

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Moderna and Merck (known as MSD outside the US) have announced five-year follow-up data from their study of intismeran autogene, in combination with Keytruda (pembrolizumab), in patients with high-risk melanoma following complete resection.

Follow-up results from the phase 2b KEYNOTE study showed that the combination treatment demonstrated sustained improvement in recurrence-free survival (RFS), which was the study’s primary endpoint. It was found to reduce the risk of recurrence or death by 49% compared with Keytruda alone.

The safety profile of the intismeran/Keytruda combination treatment at five years of follow-up was found to be consistent with its reported safety profile at two and three years.

Moderna and Merck plan to present additional study data at a future medical meeting.

Melanoma is caused by the uncontrolled growth of pigment-producing cells. Rates of the disease have been growing over the past decades, with over 330,000 new cases diagnosed globally in 2022. Skin cancer is one of the most common types of cancer diagnosed in the US, with melanoma accounting for the majority of US skin cancer deaths.


Bristol Myers Squibb’s Sotyktu approved by US FDA for psoriatic arthritis

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Bristol Myers Squibb’s (BMS) Sotyktu has been approved by the US FDA to treat adults with active psoriatic arthritis (PsA).

The approval is based on positive results from two phase 3 trials (POETYK PsA-1 and POETYK PsA-2), both showing that the drug improves disease activity.

Al Reba, senior vice president, Cardiovascular & Immunology Commercialization, Bristol Myers Squibb, said: “This latest approval of Sotyktu confirms its important role in managing both skin and joint symptoms of psoriatic disease and is a key milestone as we continue to explore its development in diseases that have limited or no treatment options.”

Sotyktu, a once-daily oral drug, is a selective tyrosine kinase 2 (TYK2) inhibitor that was approved by the US FDA in 2022 to treat adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

PsA is a chronic, immune-mediated, heterogenous disease with multiple musculoskeletal and skin manifestations, including inflammatory arthritis, enthesitis (inflammation where tendon or ligament attaches to the bone), dactylitis (swelling of finger and toe joints) and psoriatic skin and nail lesions.