Sanofi and Regeneron’s Dupixent (dupilumab) has been approved by the US Food and Drug Administration (FDA) for chronic spontaneous urticaria (CSU).

The drug has been authorised to treat the inflammatory skin disease in adults and adolescents aged 12 years and older who remain symptomatic despite histamine-1 (H1) antihistamine treatment.

CSU is characterised by red, raised, itchy and sometimes painful hives or wheals that last for six weeks or longer. The condition is usually treated with H1 antihistamines, however, more than 300,000 people in the US are living with CSU that is inadequately controlled by these medicines.

Dupixent is now the first new targeted treatment approved by the FDA for CSU in over ten years.

The FDA’s decision was supported by results from two late-stage trials, which compared Dupixent as an add-on therapy to antihistamines against antihistamines alone.

Both studies achieved their primary and key secondary endpoints, with Dupixent demonstrating reductions in itch severity and urticaria activity compared to placebo at 24 weeks.

Sanofi/Regeneron’s drug was also shown to increase the likelihood of well-controlled disease or complete response compared to placebo at 24 weeks.

The US Food and Drug Administration (FDA) has approved Abeona Therapeutics’ Zevaskyn (prademagene zamikeracel) for use in recessive dystrophic epidermolysis bullosa (RDEB).

The decision makes Zevaskyn the first autologous cell-based gene therapy approved in the US to treat wounds in adult and paediatric patients with the rare skin disorder.

RDEB is an incurable connective tissue disease characterised by extensive blistering and severe wounds.

Zevaskyn consists of a patient’s own skin cells that are genetically modified to produce functional type VII collagen, which RDEB patients are unable to produce.

The therapy is surgically applied to a patient’s wounded areas in the form of a sheet and will be available in the US from the third quarter of this year.

The FDA’s approval was supported by results from the phase 3 VIITAL study, which demonstrated significant wound healing and pain reduction after a single treatment with Zevaskyn.

In the trial, 81% of the 43 large and chronic wounds treated with a single application of Abeona’s therapy showed 50% or more healing at six months, compared to 16% in 43 matched control wounds treated with standard of care.

Researchers from the University of Birmingham (UoB) and the University of Naples Federico II have found that a sequence of three amino acids could significantly reduce the severity of psoriasis with fewer side effects than conventional treatments.

The study published in Pharmacological Research focused on the naturally occurring PEPITEM molecule, which regulates inflammation and consists of a chain of 14 amino acids.

Up to 90% of psoriasis patients have plaque psoriasis, characterised by distinct round or oval plaques covered by silvery-white scales that can be itchy and painful.

The UoB team identified the smallest parts of the PEPITEM molecule that influence immune cells and inflammation in psoriasis.

After finding and optimising two sequences of three amino acids that showed biological activity comparable to the full-length PEPITEM molecule, they chose the most promising sequence. This was then evaluated by the University of Naples Federico II using an animal model of disease.

When applied topically in an emollient cream every day for seven days, the sequence resulted in a clear reduction in psoriasis severity compared to untreated animals, confirmed using the Psoriasis Area and Severity Index.

Johnson & Johnson (J&J) has shared positive results from a phase 3b study of Tremfya (guselkumab) in adults with psoriatic arthritis (PsA).

The APEX trial has been comparing the drug against placebo in patients with active PsA who are biologic naïve and have had an inadequate response to standard therapies.

The study met its primary endpoint, with Tremfya demonstrating a significant reduction in the signs and symptoms of the disease compared to placebo.

The major secondary endpoint was also achieved, with Tremfya significantly reducing progression of structural damage, as measured by radiographic progression at 24 weeks, compared to placebo.

PsA, which causes pain, stiffness and swelling in and around the joints, affects around 30% of psoriasis patients.

Already approved in major markets to treat certain cases of active PsA, Tremfya is designed to block IL-23, an important driver of the pathogenesis of inflammatory diseases, and bind to the CD64 receptor.

The drug is now the first IL-23 inhibitor to significantly reduce both the signs and symptoms and the progression of structural damage in adults living with active PsA, according to J&J.