Almirall has announced that its IL-13 inhibitor lebrikizumab has been recommended by the European Medicines Agency’s human medicines committee to treat moderate-to-severe atopic dermatitis.
The Committee for Medicinal Products for Human Use (CHMP) has specifically recommended approval for the drug as a treatment option for adult and adolescent patients aged 12 years and older with a body weight of at least 40kg, 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 CHMP’s positive opinion is supported by results from the late-stage ADvocate1 and ADvocate2 trials evaluating lebrikizumab, now given the trade name 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, more than 50% of patients with moderate-to-severe atopic dermatitis experienced at least a 75% reduction in disease severity when receiving lebrikizumab monotherapy in the ADvocate studies, and nearly 70% of patients receiving lebrikizumab combined with standard-of-care topical corticosteroids achieved the 75% reduction in the ADhere trial.
Results from the phase 3 clinical development programme also showed that 80% of patients who responded to treatment at week 16 maintained skin clearance and itch relief through one year of treatment with monthly maintenance dosing.
The European Commission will now review the CHMP’s recommendation, with a final decision from the EU regulator expected in about two months.
Karl Ziegelbauer, chief scientific officer at Almirall, said: “The positive CHMP recommendation for Ebglyss in moderate-to-severe atopic dermatitis represents a significant milestone in bringing a next-generation biologic therapy to people living with atopic dermatitis, providing a much-needed additional treatment option.
“We are confident that Ebglyss, thanks to its selective mechanism of action, proven long-term efficacy and patient friendly monthly maintenance dosing has the potential to become a first-line treatment for moderate-to-severe atopic dermatitis.”
Almirall has licensed the rights to develop and commercialise lebrikizumab for use as a treatment of dermatology indications, including atopic dermatitis, 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.