Eli Lilly is strategically targeting both populations in an effort to compete with Dupixent’s broad label and wide patient reach, in a move that could also allow Eli Lilly to compete more fiercely with fellow JAK inhibitors Rinvoq and Cibinqo. Unlike Rinvoq and Adtralza, Olumiant is undergoing Phase III development for paediatric AD, in the BREEZE-AD PEDS (NCT03952559) study, which is enrolling both adolescents and paediatrics (aged 2–17 years).
POPULATION IN 0 AD TRIAL
Leo Pharma is also investigating Adbry/Adtralza in the 2–11 age group in a Phase II trial, TRAPEDS 1 (NCT05388760) the trial currently has an estimated primary completion date of August 2024, so there will be a long wait before interim safety and efficacy data is published. Interim data on the safety profile of the JAK inhibitor in this patient population will be key for uptake and physician opinion of the therapy. With AbbVie having initiated a Phase I (NCT03646604) safety and tolerability study investigating Rinvoq in patients aged two to 12 years, it is expected that part of AbbVie’s lifecycle management strategy for Rinvoq includes expansion to a younger patient population. This data reinforces Dupixent’s standing as a gold-standard therapy for the treatment of moderate-to-severe AD moreover, young children with severe AD are a significantly underserved population of patients, thus giving Sanofi and Regeneron a chance to capitalise on the significant gap in the market. The co-primary endpoint of Eczema Area and Severity Index (EASI-75) from baseline was met by 53% of patients treated with Dupixent versus 11% for placebo.Ī clinically meaningful and significant reduction in itch was achieved by 48% of patients treated with Dupixent compared with 9% given placebo. The primary endpoint of Investigator Global Assessment (IGA) of 0 (clear) or 1 (almost clear skin) was met by 28% of patients in the Dupixent group and 4% of patients for placebo.
POPULATION IN 0 AD PLUS
The FDA approval was based on positive efficacy and safety data from the Phase III Liberty AD PRESCHOOL (NCT03346434) trial evaluating Dupixent 200mg or 300mg (weight-based) given every four weeks plus low-potency topical corticosteroids (TCS) compared against TCS alone.
Dupixent is now the first and only biologic medicine approved to treat moderate-to-severe AD from infancy through adulthood. On 7 June, Sanofi and Regeneron announced that the US Food and Drug Administration (FDA) had approved their interleukin (IL)-4/13 inhibitor, Dupixent (dupilumab) for the treatment of children aged six months to five years with moderate-to-severe atopic dermatitis (AD) whose disease is irresponsive to topical prescription therapies or when those therapies are not advisable. Introducing the Excellence Awards & Rankings 2022.