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Almirall’s Ebglyss gains NICE recommendation for atopic dermatitis

2024-07-10

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临床3期临床结果上市批准并购生物类似药

Almirall announced Wednesday that the UK's National Institute for Health and Care Excellence (NICE) recommended Ebglyss (lebrikizumab) as a treatment option for moderate-to-severe atopic dermatitis in adolescents and adults who have previously failed on at least one systemic immunosuppressant, or when these treatments are deemed unsuitable.

The company noted that the IL-13-directed monoclonal antibody can now be prescribed routinely to eligible patients aged 12 and above weighing at least 40 kg through the NHS in England and Wales, in line with a commercial agreement which entails a simple discount patient access scheme for the drug.

Ebglyss was cleared to treat atopic dermatitis in the EU and UK last year, based on favourable findings from three Phase III studies: ADvocate 1 and ADvocate 2 evaluating the drug as monotherapy, and ADhere investigating its combination with topical corticosteroids. Results demonstrated early efficacy of Ebglyss at week 16, achieving a 75% reduction in disease extent and severity (EASI-75) in nearly six out of 10 patients.

“The NICE recommendation for lebrikizumab..is testament to the benefits this treatment can bring to patients due to its demonstrated efficacy, with 4-weekly maintenance dosing and an acceptable safety profile,” said Jorgen Damsbo, general manager at Almirall UK. Key opinion leaders interviewed by FirstWord last year said Ebglyss is at least as efficacious as Sanofi and Regeneron's Dupixent (dupilumab), with its monthly dosing being a significant advantage.

The Spanish drugmaker holds European rights to Ebglyss from Eli Lilly, which acquired the asset through its $1.1-billion takeout of Dermira in 2020. The FDA, however, turned down Lilly’s marketing application for the drug in October last year, citing third-party manufacturing issues.

rd-party manufacturing issues.

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