LEO Pharma, a leading dermatology company, announced a positive opinion from the European Medicines Agency (EMA) for Anzupgo® (delgocitinib cream). This topical treatment is intended for adults with moderate to severe chronic hand eczema (CHE), with limited approved treatment options.
Delgocitinib cream is a novel JAK inhibitor that targets the JAK-STAT signaling pathway, which plays a crucial role in CHE development. The heterogeneous nature of CHE involves skin barrier disruption, inflammation, and microbiome disruptions, leading to significant psychological and social burdens.
Data from Phase 3 trials, DELTA 1 and DELTA 2, demonstrated the safety and efficacy of delgocitinib cream compared to a placebo. The trials achieved their primary and secondary endpoints, with subjects experiencing reduced itch and pain and improvements in overall skin health. A subsequent open-label extension trial, DELTA 3, further corroborated the cream’s long-term safety.
LEO Pharma CEO Christophe Bourdon emphasizes the challenges individuals face with CHE, including potential impacts on relationships and careers. The company’s commitment to advancing treatments aligns with the unmet needs of those with this condition.
The positive CHMP opinion is a significant step towards addressing this gap. The approval process will involve review by the European Commission, and if granted, delgocitinib cream will be authorized for use throughout the EU and other participating countries. Regulatory filings are also underway in other markets.
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.
