Delgocitinib for CHE Gains EC Approval, FDA NDA Acceptance

Delgocitinib cream 20 mg/g (2%) reached major milestones in both the United States and Europe, LEO Pharma Inc. announced.

The US Food and Drug Administration (FDA) accepted a filing for a New Drug Application (NDA) for LEO Pharma’s AnzupgoÒ for the treatment of adults with moderate-to-severe chronic hand eczema (CHE) who have had an inadequate response to or for whom topical corticosteroids are not advisable. Additionally, the European Commission (EC) granted marketing authorization for the cream for the treatment of adult patients with moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.

LEO Pharma said in a press release that the FDA development “marks an important next step on LEO Pharma’s path to providing delgocitinib cream to adults living with moderate-to-severe CHE, a condition for which there are currently no FDA approved treatments.”

“Our hands are integral to every practical aspect of our lives, from our ability to work, to connecting with loved ones. Today, 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.” said Christophe Bourdon, CEO of LEO Pharma A/S. “This news is testament to our dedication to making a fundamental difference for those who need us most in medical dermatology. Alongside our ongoing efforts in Europe, we will approach our work to provide delgocitinib cream in the US with the same determination and dedication.”

The FDA submission for delgocitinib cream is based on results from the phase 3 program, which includes the DELTA 1 and DELTA 2 clinical trials that evaluated the safety and efficacy of delgocitinib cream compared to cream vehicle. Both trials met their primary and all secondary endpoints.

Delgocitinib cream is an investigational topical pan-JAK inhibitor for the treatment of moderate to severe CHE in adults. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE.

“Dermatologists regularly see the true extent to which CHE impacts patients’ lives through unique physical and psychological challenges,” said Christopher Bunick, MD, PhD, Associate Professor of Dermatology, Yale Medical School. "Many patients need more options beyond traditional topical corticosteroid use, so I welcome today’s news, which brings the prospect of a potential new treatment option one step closer for those across the US living with this debilitating condition.”