The European Medicine Agency Committee for Medicinal Products for Human Use (CHMP) has “adopted a positive opinion that recommends the approval” of delgocitinib 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 A/S announced.
Delgocitinib cream, sold by LEO Pharma as Anzupgo® , is an investigational topical pan-JAK inhibitor for CHE, according to a press release. It inhibits the activation of JAK-STAT signaling, which plays a key role in the pathogenesis of CHE, the press release said. Currently, there are no topical treatments specifically approved for adults with moderate to severe CHE for whom topical corticosteroids are inadequate or inappropriate.
“It is well known that CHE is challenging to live with and manage, potentially impacting personal relationships and careers,” Christophe Bourdon, Chief Executive Officer of LEO Pharma, said in the release. “Despite the considerable burden of the condition, treatments options approved for CHE have been limited. As an organization, we are dedicated to helping advance the standard of care for the benefit of people with skin conditions, and today we are one step closer to addressing the unmet need that may be faced by those living with CHE.”
The positive CHMP opinion 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.1,2,3 The CHMP’s positive opinion will be reviewed by the European Commission (EC) and, pending the final decision, authorization of delgocitinib cream will be valid in all EU member states, Iceland, Norway, and Liechtenstein. Regulatory filings in other markets are underway.