Almirall has announced that the National Institute for Health and Care Excellence (NICE) has recommended Ebglyss (lebrikizumab) to treat atopic dermatitis (AD) patients on the NHS in England and Wales.
NICEIL-13 inhibitorIL-13cision follows the Medicines and Healthcare products Regulatory Agency’s approval of the therapy in December. The incidence of AD appeaeczemahave increainflammatory diseases, with approximately 5.2 million adults and 2.5 million children in the UK affected by moderate or severe cases of the condition. Ebglyss, which also received approval from the European Commission last year, represents “a step forward” for uncontrolled moderate-to-severe AD patients, Almirall said, citing the therapy’s selective mechanism of action, efficacy, safety profile and four-weekly maintenance dosing.
Ebglyssulatory approvals were supported by results from the late-stage ADvocate1 and ADvocate2 trials evaluating Ebglyss as a monotherapy in adult and adolescents with moderate-to-severe AD, 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 EbglysEbglyssherapy 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 tEbglysst at week 16 maintained skin clearance and itch relief for up to two yearsEbglyssonthly maintenance dosing. Jorgen Damsbo, general manager at Almirall UK, described NICE’s recommendation as a “testament to Ebglyssefits [the] treatment can bring to patients”.itch