LEO Pharma has announced the acceptance of its New Drug Application (NDA) by the U.S. Food and Drug Administration (FDA) for delgocitinib cream 20 mg/g for adults with moderate to severe Chronic Hand Eczema (CHE). This submission marks a significant milestone in LEO Pharma’s efforts to bring this innovative treatment to patients in the United States.
Delgocitinib cream is a topical pan-JAK inhibitor that inhibits JAK-STAT signaling, a key pathway in the development of CHE. The NDA is based on positive results from Phase 3 clinical trials, which showed the drug’s safety and efficacy in treating CHE.
“This is an important step in our journey to provide new treatment options for adults suffering from moderate to severe CHE,” said Christophe Bourdon, CEO of LEO Pharma A/S. “We are committed to making a difference for those who need us most in dermatology.”
CHE is a debilitating condition that affects the hands, causing severe itching, pain, and skin inflammation. It can have a significant impact on patients’ quality of life, including their ability to work and perform everyday activities.
LEO Pharma emphasizes its commitment to addressing the unmet needs of CHE patients. The company has been actively strengthening its presence in the U.S. to support healthcare professionals in improving the lives of those living with dermatological conditions.
The FDA’s review of the NDA for delgocitinib cream is ongoing, and the company anticipates a decision by the end of 2023. If approved, delgocitinib cream would be the first FDA-approved treatment specifically for moderate to severe CHE.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
