Danish pharmaceutical company LEO Pharma has received the European Commission (EC) marketing authorisation for Anzupgo (delgocitinib) cream to treat a type of hand eczema.
Anzupgo is a topical pan-Janus kinase (JAK) inhibitor that works against the activation of JAK-STAT signalling, which is said to play an important role in the pathogenesis of CHE.
In 2014, LEO Pharma signed a license agreement with Japan Tobacco (JT) to obtain exclusive rights to develop and market the cream worldwide, except in Japan, where JT retains rights.
The EC approval indicated Anzupgo for the treatment of moderate to severe chronic hand eczema (CHE) in adults for whom topical corticosteroids are inadequate or inappropriate.
The approval follows the positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
In addition, LEO Pharma announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for Anzupgo cream in the US.
LEO Pharma CEO Christophe Bourdon said: “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.
“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.”
CHE is a heterogeneous, fluctuating, inflammatory skin disease characterised by skin barrier dysfunction, skin inflammation and skin microbiome alterations.
The EC approval of Anzupgo cream is based on results from Phase 3 DELTA 1 and DELTA 2 clinical trials, which evaluated the safety and efficacy of Anzupgo compared to a cream vehicle.
Both clinical trials met their primary endpoint of Investigator’s Global Assessment for chronic hand eczema treatment success (IGA-CHE TS) at Week 16.
They also met all the key secondary endpoints, including reduction of itch and pain scores of ≥4 points measured by the Hand Eczema Symptom Diary (HESD).
Participants who completed the DELTA 1 or DELTA 2 studies were immediately offered to enrol in the 36-week DELTA 3 open-label extension trial to evaluate the long-term safety of Anzupgo.
LEO Pharma chief development officer Kreesten Meldgaard Madsen said: “This approval is the culmination of years of focus and effort, driven every day by the goal to support this patient population.
“The new treatment option aims to support the management of this debilitating condition, given the limited treatment options for CHE currently approved across Europe.”
