The UK-based Medicines and Healthcare products Regulatory Agency (MHRA) has recently approved Leo Pharma’s delgocitinib (Anzupgo) for the treatment of moderate to severe chronic hand eczema (CHE) in adults. This approval represents a significant milestone in the field of dermatology because it offers a new therapeutic model for patients who have not responded adequately to existing treatments such as topical steroids and emollients.

Mode of Action: Delgocitinib is a topical pan-Janus kinase (JAK) inhibitor and works by targeting and inhibiting the activity of four specific JAK enzymes (i.e. JAK1, JAK2, JAK3 and TYK2). These enzymes are integral to signalling pathways that lead to both inflammatory and immune responses. By blocking these pathways, delgocitinib reduces inflammation, itching and pain associated with eczema. As a result, the quality of life for patients is improved.

Efficacy: Clinical trials have demonstrated the efficacy of delgocitinib in managing CHE. Patients treated with delgocitinib demonstrated significant improvements in their skin condition (e.g. reductions in redness, scaling and fissuring). Interestingly, this drug helped to restore the skin barrier function that is often weakened in eczema patients. Improvements were noted in only a few weeks of drug exposure and this clearly highlights the rapidity of action for this medicine.

Patient Safety: Common side effects of delgocitinib include application site reactions such as burning or stinging sensations, which are generally mild and transient; this class of adverse reaction would indeed be anticipated. Serious adverse effects appear to be rare, but as per the norm ongoing monitoring is required. Here, the MHRA will continue to oversee the safety and efficacy of delgocitinib through post-marketing surveillance and the Yellow Card scheme, where healthcare professionals and patients can report any adverse effects.

Regulatory Approval: The approval process for delgocitinib was fast tracked under the International Recognition Procedure (IRP) Route B, with the European Medicines Agency (EMA) acting as the Reference Regulator. The marketing authorisation was granted in only fifty nine days! This rapid approval clearly highlights the pressing need for new treatments for moderate to severe CHE. The area of medical practice as a whole is noted to have significant unmet need.

Healthcare Practice: For pharmacy and medical students, plus qualified healthcare professionals, an awareness and understanding of the approval and mechanism of delgocitinib is very important. This agent represents a new class of treatment for CHE, offering an alternative for patients with limited options. It also highlights the growing importance of JAK inhibitors in the management of inflammation. Naturally, healthcare professionals should be aware of the drug's indication, mode of action and safety profile to effectively counsel patients and monitor treatment outcomes.

The Future: The approval of delgocitinib will undoubtedly stimulate additional research into JAK inhibitors for other medical complaints caused by inflammation. Ongoing studies may consider autoimmune diseases such as rheumatoid arthritis for example. This could lead to broader applications and improved patient outcomes for this class of drug.