The European Commission (E.C.) has given its official nod to delgocitinib (Anzupgo, Leo Pharma) cream for adults with moderate to severe chronic hand eczema (CHE).
In addition, the U.S. Food and Drug Administration has accepted LEO Pharma’s filing of a new drug application for delgocitinib cream in CHE.
Delgocitinib, a topical pan-Janus kinase (JAK) inhibitor, is the first topical treatment to be specifically indicated for adult patients living with moderate to severe CHE across the European Union (EU) for whom topical corticosteroids are inadequate or inappropriate.
The European approval follows the recent positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) and is based on results from the DELTA phase 3 program. These trials evaluated the safety and efficacy of delgocitinib compared to cream vehicle. Both trials met their primary and all secondary endpoints. Subjects who completed the 16-week DELTA 1 or DELTA 2 trials were immediately offered to enroll in the 36-week DELTA 3 open-label extension trial.
In the U.S., the new drug application, if approved, would make delgocitinib cream the first treatment specifically indicated for adults with moderate to severe CHE.
“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,” says Christophe Bourdon, CEO of LEO Pharma A/S in a news release. “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 U.S. with the same determination and dedication.”
The U.S. regulatory 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.
“Dermatologists regularly see the true extent to which CHE impacts patients’ lives through unique physical and psychological challenges,” says TDD Editorial Advisory Board Member Christopher Bunick, MD, PhD, Associate Professor of Dermatology, Yale Medical School, in a news release. “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 U.S. living with this debilitating conditions.”
