CMS(00867): Phosphate retinoic acid cream (vitiligo indication) application for marketing authorization in China has been accepted.

CMS (00867) announced that the application for the new drug market approval of LUCATIONI (vitiligo indication) ("LUCATIONI Cream" or "Product") has been accepted by the National Medical Products Administration of China (NMPA) on September 24, 2024. LUCATIONI Cream has achieved positive results in real-world studies in China. The proportion of patients reaching F-VASI 75 at week 24 in the treatment group was 49.5%, significantly higher than the target value of 14.1% (P <0.0001), achieving the primary endpoint, proving that LUCATIONI Cream can effectively treat non-segmental vitiligo patients, reduce skin lesions, and restore skin color. All secondary efficacy endpoints showed a consistent benefit trend with the primary efficacy endpoint, and the longer the treatment time, the better the treatment effect of vitiligo in patients. The severity of adverse reactions were all grade 1 or grade 2, no adverse events (AE) leading to discontinuation or blistering occurred, and no serious adverse events related to the study drug (SAE) were reported. Vitiligo is a chronic autoimmune disease characterized by the loss of skin pigment, caused by the absence of melanocytes, the cells that produce pigment. It is estimated that there are approximately 14 million vitiligo patients in China and about 6.5 million in eleven countries in Southeast Asia. Approximately 85% of vitiligo patients have non-segmental vitiligo. Topical corticosteroids (TCS) and calcineurin inhibitors (CI) are labeled topical drugs for non-segmental vitiligo, however, these therapies have clinical limitations, with adverse reactions or limited efficacy with long-term use.