Almirall receives European Commission approval of EBGLYSS® for atopic dermatitis

Almirall S.A. (BME:ALM), a global biopharmaceutical company focused on medical dermatology, announced today that the European Commission (EC) has approved EBGLYSS (lebrikizumab) for the treatment of adult and adolescent patients (12 years and older with a bodyweight of at least 40 kg) with moderate-to-severe atopic dermatitis (AD), who are candidates for systemic therapy. Almirall will first start the commercial launch in Germany. The company will continue the rollout in further European countries throughout 2024.

Lebrikizumab represents a significant step forward in patients with moderate-to-severe AD not controlled with topical therapy due to its selective mechanism of action, proven short and long-term efficacy and safety demonstrated up to 2 years and a monthly maintenance dosing for all patients.

“The EC approval provides another much-needed treatment option for this challenging disease. This regulatory milestone again highlights Almirall’s commitment to develop innovative treatments that can make a meaningful difference in the lives of people with skin diseases," stated Dr. Volker Koscielny, Chief Medical Officer at Almirall.

"We are facing a qualitative leap in the treatment of atrophic dermatitis thanks to biologists. Lebrikizumab represents a major breakthrough, with an innovative mechanism of action that allows us to offer an effective therapeutic alternative with few side effects. For health professionals, it offers an opportunity to improve the treatment of the disease and have a positive impact on patients' lives," says Dr. José Manuel Carrascosa, head of the Dermatology Department at the Germans Trias i Pujol Hospital.

Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including atopic dermatitis, in Europe. Eli Lilly and Company has exclusive rights for the development and commercialization of the product in the United States and the rest of the world, not including Europe. Almirall expects regulatory decisions for lebrikizumab in moderate-to-severe atopic dermatitis in additional European markets, including the United Kingdom and Switzerland.