The European Commission (EC) has granted marketing authorization for LEO Pharma’s Anzupgo (delgocitinib) cream for the treatment of adult patients with moderate to severe chronic hand eczema (CHE) for whom topical corticosteroids are inadequate or inappropriate.
The EC approval is valid in all European Union Member States, Iceland, Norway, and Liechtenstein.
“We are dedicated to advancing the standard of care for those living with skin conditions, and this long-awaited milestone for Anzupgo demonstrates our purpose in practice,” said Christophe Bourdon, Chief Executive Officer, LEO Pharma. “This approval provides a new treatment option for patients, and we look forward to coordinating the next steps required to provide Anzupgo to those patients who need it.”
Anzupgo is a topical pan-JAK inhibitor for the treatment of moderate to severe CHE. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE. Currently, there are no other topical treatments specifically approved for adults with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate.
“This approval is the culmination of years of focus and effort, driven every day by the goal to support this patient population,” said Kreesten Meldgaard Madsen, Chief Development Officer, LEO Pharma. “The new treatment option aims to support the management of this debilitating condition, given the limited treatment options for CHE currently approved across Europe.”
CHE is a heterogeneous, fluctuating, inflammatory skin disease with key symptoms of itch and pain. Its pathophysiology is characterized by skin barrier dysfunction, skin inflammation, and skin microbiome alterations. The condition can have a high psychological, social, and occupational burden.
The approval for Anzupgo 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 Anzupgo 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.
