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 cream is intended for adult
patients with moderate to severe chronic hand eczema (CHE) who have not responded adequately to topical corticosteroids. The NDA has been accepted for review, supported by results from the DELTA China phase 3 trial and other clinical programs. Anzupgo is already approved in several countries, including the European Union, Canada, and South Korea, for similar indications. The submission marks a significant step in providing new treatment options for patients in China, where no specific treatments for moderate to severe CHE are currently approved.
Why It's Important?
The submission of Anzupgo's NDA in China is crucial as it addresses a significant unmet medical need for patients suffering from chronic hand eczema, a condition that can severely impact quality of life and daily functioning. If approved, Anzupgo could offer a new therapeutic option for patients who have limited treatment choices, potentially improving their quality of life and reducing the psychological and functional burdens associated with the disease. This move also underscores LEO Pharma's commitment to expanding its global footprint and enhancing skin health solutions in key markets like China.
What's Next?
Following the acceptance of the NDA by the Centre for Drug Evaluation (CDE), the full evaluation process has commenced, with a conclusion expected by 2027. If successful, Anzupgo will be introduced to the Chinese market, providing a new treatment option for patients with chronic hand eczema. LEO Pharma will continue to invest in clinical trials and regulatory processes to support the approval and commercialization of Anzupgo in China.
Beyond the Headlines
The introduction of Anzupgo in China could lead to broader discussions on the availability and accessibility of dermatological treatments in the region. It may also prompt further research into chronic hand eczema and its impact on patients' lives, potentially influencing healthcare policies and practices related to skin diseases.
