Lilly seeks eczema label update after hand-and-foot study meets endpoints

Lilly ($LLY) said EBGLYSS achieved clear or almost clear hands and feet in 53% of treated patients after 16 weeks, compared with 27% on placebo, in the randomized ADtouch study. The 221-patient trial included adults and adolescents with moderate-to-severe hand-and-foot atopic dermatitis. A substantial improvement in itch occurred in 57% of eligible treated participants versus 19% receiving placebo.

Lilly has submitted the results to the FDA for a possible label update and plans additional regulatory submissions. The findings could strengthen the product’s position in a difficult-to-treat manifestation of eczema, but they do not constitute a new authorization. Treatment-emergent adverse events occurred in 41.8% and 39.6% of the treatment and placebo groups, respectively; the company reported no new safety signal.

Sources:

• Company release via PR Newswire