Delgocitinib cream 2% NDA accepted by FDA for chronic hand eczema

Key takeaways:

• The FDA has accepted the filing for delgocitinib cream 2% for the treatment of chronic hand eczema.
• The application was supported by the phase 3 DELTA trials.

The new drug application for delgocitinib cream 2% has been accepted by the FDA for the treatment of patients with moderate to severe chronic hand eczema, LEO Pharma announced in a press release.

Delgocitinib cream is an investigational topical pan-Janus kinase inhibitor that is indicated for patients with moderate to severe chronic hand eczema (CHE) who did not initially have adequate responses to or were unable to use topical corticosteroids.

“I am incredibly proud that LEO Pharma is taking a step towards addressing the long-standing unmet need in CHE for those in the U.S.” Christophe Bourdon, MBA, CEO of LEO Pharma, said in the press release. “This news is testament to our dedication to making a fundamental difference for those who need us most in medical dermatology.”

According to the release, this submission was supported by results from the phase 3 DELTA program, which met its primary and secondary endpoints. The company anticipates that the review process for this application will be completed in the second half of 2025.