LEO Pharma A/S said that the European Medicines Agency (EMA) has validated its marketing authorization application (MAA) for delgocitinib cream. Touted as a groundbreaking topical pan-Janus kinase (JAK) inhibitor, this cream is specifically designed for adult patients battling moderate to severe chronic hand eczema (CHE). This validation kicks off the official review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).

First-of-its-kind solution for chronic hand eczema patients

“We’re on the cusp of introducing the first-ever topical solution expressly tailored for moderate to severe CHE,” declares Kreesten Meldgaard Madsen, Chief Development Officer at LEO Pharma. He further emphasizes the company’s unwavering commitment to uplifting the lives of people with skin disorders.

Dr Jacob Pontoppidan Thyssen, Executive Vice President and Chief Scientific Officer of LEO Pharma, highlights the stark reality: around 9% suffer from CHE, yet no specific topical treatments are available for its moderate to severe form. “This MAA is a beacon of hope for patients and is testimony to LEO Pharma’s dedication to fulfilling a severe unmet need in CHE.”

Understanding delgocitinib and chronic hand eczema

Chronic hand eczema is not just any skin disease; it’s a multifaceted, recurring inflammatory ailment, causing patients discomfort from itchiness, pain, and a slew of other psychological and occupational challenges. Delgocitinib promises to be a pioneering topical pan-JAK inhibitor for chronic hand eczema, targeting the JAK-STAT signaling pathway, crucial in the disease’s pathogenesis.

Clinical trials exhibit encouraging results

The MAA’s foundation rests on data from phase 3 trials, primarily the DELTA 1 and DELTA 2 studies, which focused on the safety and effectiveness of delgocitinib against a control cream. Both these trials successfully met their primary and secondary objectives. Additionally, the ongoing DELTA 3 extension trial, which examines delgocitinib’s long-term safety, also contributes to the MAA. The principal goal for these clinical tests was to discern the benefits of twice-daily delgocitinib applications for adults with moderate to severe chronic hand eczema. Key outcomes included a marked reduction in itch and pain, substantial improvement in the Hand Eczema Severity Index (HECSI) at Week 16, and the documentation of any treatment-related adverse events during this period.

A potential game-changer for chronic hand eczema

As the clinical community eagerly awaits the EMA’s final verdict, the promise of delgocitinib, with its potent inhibitory action on the JAK-STAT signaling, positions it as a potential revolutionary treatment in the world of dermatology, potentially changing the lives of those living with chronic hand eczema.

  CHMP, chronic hand eczema, delgocitinib, Dermatology, Dr Jacob Pontoppidan Thyssen, eczema, Europe, European Medicines Agency, Kreesten Meldgaard Madsen, LEO Pharma, Skin Disorders