LEO LABORATORIES LIMITED

September 2024 FDA updates include approvals for Embecta's tubeless patch pump for diabetes, Travere Therapeutics' sparsentan for IgA nephropathy, Johnson & Johnson's guselkumab for ulcerative colitis, and the first over-the-counter hearing aid software device. Other approvals cover treatments for conditions like chronic rhinosinusitis with nasal polyps, atopic dermatitis, eosinophilic granulomatosis with polyangiitis, Niemann-Pick disease type C, and schizophrenia. The FDA also issued warnings and accepted NDAs for various treatments, including delgocitinib cream for chronic hand eczema and roflumilast foam for psoriasis.

Nine months of tralokinumab treatment improved itch, sleep quality, and overall quality of life in adult atopic dermatitis patients, according to interim TRACE study results presented at the 2024 EADV Congress.

Nemolizumab therapy showed continuous improvements in atopic dermatitis symptoms up to 56 weeks, with 47% achieving clear or almost clear skin and 73% improving EASI scores by 75%. Nemolizumab, an IL-31 receptor antagonist, demonstrated a favorable safety profile with no unexpected adverse events, positioning it as a valuable long-term treatment option for atopic dermatitis.

Leo Pharma applies in China for approval of its psoriasis drug Enstilar for adult plaque psoriasis treatment.

LEO Pharma's Anzupgo (delgocitinib) cream, a pan-Janus kinase inhibitor, is the first topical treatment approved by the European Commission for moderate-to-severe chronic hand eczema in adults unresponsive to topical corticosteroids. The approval is based on positive results from DELTA 1, DELTA 2, and DELTA 3 trials, showing efficacy in reducing symptoms and maintaining safety. LEO Pharma also announced the FDA's acceptance of its new drug application for delgocitinib cream, with a review expected by mid-2025.

LEO Pharma's NDA for delgocitinib cream 20 mg/g (2%) for chronic hand eczema (CHE) was accepted by the US FDA. Delgocitinib, a pan-Janus kinase (JAK) inhibitor, targets JAK-STAT signaling, a key pathogenesis factor in CHE. If approved, it would be the first US therapy for adults with moderate-to-severe CHE unresponsive to or unable to use topical corticosteroids. The FDA's decision is based on positive phase 3 DELTA 1 and DELTA 2 trial results, with anticipated regulatory review completion in H2 2025.

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 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 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.