What's Happening?
LEO Pharma has submitted a New Drug Application (NDA) to China's National Medical Products Administration for Anzupgo (delgocitinib) cream, intended for adult patients with moderate to severe chronic hand
eczema. The NDA is supported by results from the DELTA China phase 3 trial, which demonstrated significant improvement in eczema severity after 16 weeks of treatment. Anzupgo is a topical pan-Janus kinase (JAK) inhibitor, already approved in several countries, including the U.S., for similar indications. The submission marks a significant step in expanding treatment options for chronic hand eczema in China, where no specific treatments are currently approved.
Why It's Important?
The submission of Anzupgo's NDA in China represents a potential advancement in dermatological treatment options for chronic hand eczema, a condition that significantly impacts quality of life and daily functioning. If approved, Anzupgo could address a substantial unmet medical need, offering relief to patients who have inadequate responses to existing treatments. This move underscores LEO Pharma's commitment to global expansion and innovation in medical dermatology, potentially setting a precedent for further international collaborations and market entries. The approval could also enhance LEO Pharma's presence in the Chinese market, a key area for growth in the pharmaceutical industry.
What's Next?
Following the acceptance of the NDA by China's Centre for Drug Evaluation, the regulatory review process is underway, with a conclusion expected by 2027. If successful, Anzupgo will be introduced to the Chinese market, providing a new treatment option for chronic hand eczema. LEO Pharma may continue to leverage its global expertise to expand its product offerings in China and other markets, potentially leading to further submissions and approvals. The ongoing DELTA China trial will provide additional data to support the cream's efficacy and safety, influencing future regulatory decisions and market strategies.
