Delgocitinib

Leo Pharma launches JAK inhibitor Anzupgo in Denmark after debuting in Germany.

LEO Pharma launches Anzupgo (delgocitinib) cream in Germany for moderate to severe chronic hand eczema, following EC approval. Anzupgo is a topical JAK inhibitor addressing unmet needs, with phase 3 trials showing efficacy and safety. Germany is the first country to offer this treatment, with regulatory filings ongoing in other markets.

The Pink Sheet's EU centralized approvals list updated with four new products, including Anzupgo by LEO Pharma for moderate to severe chronic hand eczema in adults.

Germany is the first country to launch Anzupgo, a topical treatment for moderate to severe Chronic Hand Eczema (CHE) where topical corticosteroids are inadequate or inappropriate. This new treatment addresses a significant unmet need for the estimated 3.9 million people in Germany living with CHE.

LEO Pharma launches delgocitinib (Anzupgo) cream in Germany, the first country to offer the treatment for moderate to severe chronic hand eczema (CHE). The European Commission approved delgocitinib for patients unresponsive to topical corticosteroids, applicable across EU member states, Norway, Iceland, and Liechtenstein. The decision was based on phase 3 DELTA trials showing significant improvements in clinical symptoms, with DELTA 3 extension trial demonstrating long-term safety and sustained efficacy.

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.

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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.