Almirall has announced that the National Institute for Health and Care Excellence (NICE) has recommended Ebglyss (lebrikizumab) to treat atopic dermatitis (AD) patients on the NHS in England and Wales.

The IL-13 inhibitor can now be used to treat moderate-to-severe AD in adults and adolescents aged 12 years and older with a body weight of at least 40kg and who are candidates for systemic therapy.

NICE’s decision follows the Medicines and Healthcare products Regulatory Agency’s approval of the therapy in December.

The incidence of AD appears to have increased in recent decades, with approximately 5.2 million adults and 2.5 million children in the UK affected by moderate or severe cases of the condition.

Ebglyss represents “a step forward” for uncontrolled moderate-to-severe AD patients, Almirall said, citing the therapy’s selective mechanism of action, efficacy, safety profile and four-weekly maintenance dosing.

The regulatory approvals were supported by results from the late-stage ADvocate1 and ADvocate2 trials evaluating Ebglyss as a monotherapy in adult and adolescents with moderate-to-severe AD, as well as data from the phase 3 ADhere study assessing the drug in combination with topical corticosteroids.

At week 16, almost 60% of patients experienced at least a 75% reduction in disease severity when receiving Ebglyss monotherapy in the ADvocate studies and nearly 70% of patients receiving Ebglyss combined with standard-of-care topical corticosteroids achieved the 75% reduction in the ADhere trial.

Results from the clinical development programme also showed that 80% of patients who responded to Ebglyss treatment at week 16 maintained skin clearance and itch relief for up to two years with monthly maintenance dosing.

Almirall has licenced the rights to develop and commercialise Ebglyss for use as a treatment for dermatology indications in Europe, while Eli Lilly has exclusive rights for the development and commercialisation of the drug in the US and the rest of the world.