FDA Accepts NDA for Delgocitinib Cream to Treat Chronic Hand Eczema
LEO Pharma expects the regulatory review process to be completed in the second half of 2025.
The FDA has accepted the filing of a new drug application (NDA) for delgocitinib cream for the treatment of moderate to severe chronic hand eczema in adults, LEO Pharma announced in a release.1 The company said it expects the regulatory review process to be completed in the second half of 2025.
FDA Accepts NDA for Delgocitinib Cream to Treat Chronic Hand Eczema / Ольга Тернавская - stock.adobe.com
The NDA submission was supported by data from the DELTA 1 (NCT04871711) and DELTA 2 (NCT04872101) trials, which showed that delgocitinib cream met its primary endpoint of an Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) score of 0 or 1. Additional data from the DELTA 3 (NCT04949841) extension trial also showed that delgocitinib cream was well tolerated after 36 weeks of treatment.
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“Dermatologists regularly see the true extent to which CHE impacts patients’ lives through unique physical and psychological challenges,” Christopher Bunick, MD, PhD, Associate Professor of Dermatology at Yale Medical School, said in a release.1 "Many patients need more options beyond traditional topical corticosteroid use, so I welcome today’s news, which brings the prospect of a potential new treatment option one step closer for those across the US living with this debilitating condition.”
DELTA 1 and DELTA 2 were randomized, double-blinded, vehicle-controlled phase 3 studies that assessed twice-daily 20 mg/g delgocitinib cream or cream vehicle for 16 weeks in adult patients with moderate to severe chronic hand eczema. DELTA 1 took place at 53 trial centers in Canada, France, Germany, Italy, Poland, and the UK. DELTA 2 took place at 50 trial centers in Belgium, Canada, Denmark, Germany, the Netherlands, Poland, and Spain.
Investigators found that a greater proportion of patients treated with delgocitinib cream had IGA-CHE treatment success compared to those who received cream vehicle after 16 weeks. Additionally, the proportion of adverse events was similar between the 2 groups. The most common adverse events were COVID-19 and nasopharyngitis.
Participants who completed the 16-week DELTA 1 or DELTA 2 trials were extended the offer to enroll in the 36-week DELTA 3 open-label extension trial. The study evaluated the long-term safety of delgocitinib cream up to 36 weeks. Patients visited a clinic every 4 week to assess the safety and efficacy of the treatment, with a final phone call on week 38. Data from the trial showed the therapy was well tolerated and that patients maintained previous levels of symptom relief.
“Our hands are integral to every practical aspect of our lives, from our ability to work, to connecting with loved ones,” Christophe Bourdon, CEO of LEO Pharma, said in a release.1 “Today, I am incredibly proud that LEO Pharma is taking a step towards addressing the long-standing unmet need in chronic hand eczema for those in the US This news is testament to our dedication to making a fundamental difference for those who need us most in medical dermatology.”
LEO also announced that delgocitinib cream (Anzupgo) was approved by the European Commission for the treatment of moderate to severe chronic hand eczema in adult patients for whom topical corticosteroids are inadequate or inappropriate.2 The approval is valid in all countries that are members of the European Union, as well as Iceland, Norway, and Liechtenstein.
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References
1. FDA Accepts LEO Pharma’s Filing of Delgocitinib Cream New Drug Application for the Treatment of Chronic Hand Eczema. News Release. LEO Pharma. September 23, 2024. Accessed September 23, 2024. https://www.leo-pharma.com/media-center/news/2024-fda-accepts-leo-pharma-filing-of-delgocitinib
2. European Commission Approves LEO Pharma’s Anzupgo® (delgocitinib) Cream for Adults with Moderate to Severe Chronic Hand Eczema (CHE). News Release. LEO Pharma. September 23, 2024. Accessed September 23, 2024. https://www.leo-pharma.com/media-center/news/2024-european-commission-approves-leo-pharma-anzupgo
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