The National Institute for Health and Care Excellence (NICE) now recommends lebrikizumab (Ebglyss, Almirall S.A.) for use in moderate to severe atopic dermatitis (AD) in the NHS England.
The interleukin-13 blocker is indicated for the treatment of adult and adolescent patients (12 years and older with a body weight of at least 40 kg) with moderate to severe AD, who are candidates for systemic therapy. The treatment was approved by the European Commission and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in December 2023.
Almirall has licensed the rights to develop and commercialize lebrikizumab for the treatment of dermatology indications, including AD, 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 AD in additional European markets, including the United Kingdom and Switzerland in 2024.
Eli Lilly and Company recently announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the lebrikizumab biologic license application (BLA) for the treatment of moderate-to-severe AD. The letter cited findings that arose during a multi-sponsor inspection of a third-party, contract manufacturing organization that included the monoclonal antibody drug substance for Lilly’s lebrikizumab. The letter stated no concerns about the clinical data package, safety, or label for lebrikizumab.
“That lebrikizumab is now reimbursed by NICE is great news for patients as it adds another much-needed targeted biologic to the treatment options already available for Atopic Dermatitis,” says Richard Weller, MRCP, a Professor of Medical Dermatology at the University of Edinburgh in Scotland and ab honorary consultant dermatologist, in a news release.
