Delgocitinib

LEO Pharma's FDA filing for delgocitinib cream, a potential first U.S. treatment for moderate to severe Chronic Hand Eczema (CHE), marks progress in addressing a condition affecting 4.7% globally. The phase 3 trials met primary and secondary endpoints, offering hope for a new treatment option.

LEO Pharma's NDA for delgocitinib cream, a topical pan-JAK inhibitor for moderate to severe Chronic Hand Eczema (CHE), accepted by FDA. Based on Phase 3 trials showing safety and efficacy, it could be the first FDA-approved CHE treatment, with a decision expected by end of 2023.

LEO Pharma secures EC approval for Anzupgo cream, a topical pan-JAK inhibitor for moderate to severe chronic hand eczema in adults. The approval follows positive CHMP recommendation and includes an FDA NDA acceptance in the US. Anzupgo aims to address limited treatment options for CHE.

FDA accepts LEO Pharma's NDA for delgocitinib cream 20 mg/g (2%) to treat moderate to severe Chronic Hand Eczema (CHE) in adults, marking a significant step towards addressing the unmet need for CHE treatment in the U.S. Delgocitinib cream is an investigational topical pan-JAK inhibitor that inhibits JAK-STAT signaling, crucial in CHE pathogenesis. The submission is based on phase 3 DELTA 1 and DELTA 2 trials, which met primary and secondary endpoints, offering long-term safety data in the DELTA 3 extension trial. The regulatory review is expected to conclude in the second half of 2025.

The FDA accepted a new drug application for delgocitinib cream to treat moderate to severe chronic hand eczema (CHE), a condition affecting quality of life and occupational abilities. Delgocitinib, a topical JAK inhibitor, showed promise in clinical trials, offering a potential new treatment beyond corticosteroids.

LEO Pharma's delgocitinib cream for Chronic Hand Eczema (CHE) achieves FDA NDA filing acceptance and EC marketing authorization as Anzupgo in EU. The cream targets adults with moderate to severe CHE unresponsive to topical corticosteroids, with no FDA-approved treatments in the US. Supported by phase 3 trials, delgocitinib's US approval is expected in H2 2025.

The FDA accepted LEO Pharma's NDA for delgocitinib cream for chronic hand eczema, potentially marking the first US approval for moderate to severe CHE treatment. The cream, a JAK inhibitor, targets JAK-STAT signaling, crucial in the disease's pathogenesis. Based on DELTA 1 and 2 trials, delgocitinib showed significant efficacy in IGA-CHE TS, with 20% and 29% success rates, respectively, compared to vehicle cream. LEO Pharma aims to address the unmet need for CHE patients, emphasizing potential impacts on quality of life.

LEO Pharma's NDA for delgocitinib cream, a potential treatment for moderate to severe Chronic Hand Eczema (CHE), has been accepted by the FDA. If approved, it would be the first treatment in the U.S. specifically for adults with CHE, a condition affecting 4.7% of the global population.