Almirall has announced that its IL-13 inhibitor Ebglyss (lebrikizumab) has been approved by the European Commission (EC) to treat moderate-to-severe atopic dermatitis.

The regulator has specifically approved the drug as a treatment option for adult and adolescent patients aged 12 years and older with a body weight of at least 40kg and who are candidates for systemic therapy.

Typically referred to as eczema, atopic dermatitis is a chronic, inflammatory disease of the skin characterised by recurrent inflammation associated with intense pruritus or itching.

The incidence of atopic dermatitis appears to have increased in recent decades, currently affecting an estimated 4.4% of adults in the EU.

The EC’s decision, which follows a recent recommendation from the European Medicines Agency’s human medicines committee, is supported by results from the late-stage ADvocate1 and ADvocate2 trials evaluating Ebglyss as a monotherapy in adult and adolescent patients with moderate-to-severe atopic dermatitis, 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.

Dr Volker Koscielny, chief medical officer at Almirall, said: “The EC approval of [Ebglyss] for people suffering with moderate-to-severe atopic dermatitis provides another much-needed treatment option for this challenging disease.

"We are confident that due to its demonstrated short and long-term efficacy, with monthly maintenance dosing and a consistent safety profile, it has the potential to become a first-line biologic treatment."

Almirall has licensed 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.

https://www.pmlive.com/pharma_news/almirall_granted_ec_approval_for_ebglyss_in_moderate-to-severe_atopic_dermatitis_1504011