UK MHRA Grants Marketing Authorization to Leo Pharma’s Delgocitinib to Treat Adult Patients with Moderate to Severe Chronic Hand Eczema
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine delgocitinib (Anzupgo) to treat moderate to severe chronic hand eczema in adults when topical corticosteroids are inadequate or inappropriate.
Chronic hand eczema is an inflammatory skin condition that causes symptoms such as itching and pain.
The new marketing authorisation was granted in 59 days on 29 November 2024 to Leo Pharma AS under the International Recognition Procedure (IRP) Route B.
Anzupgo contains the active substance delgocitinib, which belongs to a group of medicines called Janus kinase inhibitors.
Delgocitinib works by blocking the activity of four specific Janus kinase enzymes, which helps reduce inflammation and immune responses that cause hand eczema. By suppressing these processes, delgocitinib can help to reduce inflammation of the skin, itching and pain. This, in turn, can increase the ability to perform daily activities and can improve the quality of life.
As with any medicine, the MHRA will keep the safety and effectiveness of delgocitinib under close review. Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe. All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
The MHRA is an executive agency of the Department of Health and Social Care