What's Happening?
LEO Pharma has announced the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA) in China for Anzupgo® (delgocitinib) cream. This application aims to treat adult patients with moderate to severe chronic hand
eczema (CHE) who have not responded adequately to topical corticosteroids. The NDA is supported by results from the DELTA China phase 3 trial, which demonstrated significant improvement in CHE severity after 16 weeks of treatment with Anzupgo. The trial involved 362 subjects and is part of a broader clinical program that includes data from several other trials. LEO Pharma, a global leader in medical dermatology, is committed to expanding treatment options for skin diseases in China, marking a significant step in addressing unmet medical needs in the region.
Why It's Important?
The submission of Anzupgo's NDA in China is a critical development in the field of dermatology, particularly for patients suffering from chronic hand eczema. This condition significantly impacts quality of life and daily functioning, with no approved treatments specifically indicated for moderate to severe CHE in China. If approved, Anzupgo could fill this treatment gap, offering relief to many patients. The move also underscores LEO Pharma's strategic focus on expanding its presence in the Chinese market, which is vital for the company's growth. The approval of Anzupgo in China could set a precedent for further regulatory submissions and approvals in other regions, enhancing LEO Pharma's global footprint.
What's Next?
Following the acceptance of the NDA by the Centre for Drug Evaluation (CDE), the regulatory review process is underway and is expected to conclude by 2027. During this period, LEO Pharma will likely continue to engage with Chinese regulatory authorities to facilitate the approval process. The company may also prepare for potential market entry strategies, including partnerships and distribution plans, to ensure a successful launch upon approval. Additionally, the ongoing open-label treatment period of the DELTA China trial will provide further data to support the efficacy and safety of Anzupgo, which could influence the final decision by the NMPA.
Beyond the Headlines
The introduction of Anzupgo in China could have broader implications for the treatment of skin diseases globally. It highlights the growing importance of targeted therapies in dermatology, particularly those addressing specific pathways like the JAK-STAT signaling involved in CHE. This development may encourage further research and innovation in similar therapeutic areas, potentially leading to new treatment options for other chronic skin conditions. Moreover, LEO Pharma's commitment to the Chinese market reflects the increasing globalization of pharmaceutical companies, aiming to address diverse patient needs across different regions.
