Nemolizumab Approved to Treat Prurigo Nodularis and Atopic Dermatitis in the UK
Date: February 17, 2025
Source: GOV UK
Details:
The Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has approved the use of nemolizumab for the treatment of moderate-to-severe prurigo nodularis (PN) and moderate-to-severe atopic dermatitis (eczema) in patients aged 12 years and older.
Nemolizumab is a humanized monoclonal antibody that binds to the interleukin-31 receptor (IL-31R), blocking the signaling of IL-31, a cytokine involved in inflammation and itch.
Prurigo Nodularis:
PN is a chronic skin condition characterized by extremely itchy nodules or bumps on the skin. It can cause severe discomfort and impact quality of life.
Atopic Dermatitis:
Eczema is a common inflammatory skin condition that causes dry, itchy, and inflamed skin. Moderate-to-severe eczema can be debilitating, affecting sleep, mood, and daily activities.
Clinical Trials:
The approval of nemolizumab for PN and eczema is based on data from two Phase 3 clinical trials.
PN Trial:
In the PN trial, nemolizumab significantly reduced itch intensity and the number of nodules compared to placebo after 16 weeks.
Eczema Trial:
In the eczema trial, nemolizumab improved skin clearance and reduced itch and inflammation compared to placebo after 16 weeks.
Dosing and Administration:
Nemolizumab is administered as a subcutaneous injection every four weeks. The recommended dose is 300 mg for adults and adolescents weighing 60 kg or more and 200 mg for adolescents weighing less than 60 kg.
Safety and Side Effects:
Nemolizumab has been generally well-tolerated in clinical trials. The most common side effects include headache, fatigue, injection site reactions, and nausea.
Availability:
Nemolizumab is expected to become available in the UK in the coming months. It will be prescribed by dermatologists and other healthcare professionals who specialize in treating skin conditions.
Significance:
The approval of nemolizumab in the UK provides a new treatment option for patients with moderate-to-severe PN and eczema. It is the first monoclonal antibody approved specifically for the treatment of PN and offers a potential breakthrough in the management of this debilitating condition.
Additional Information:
- Nemolizumab was developed by Incyte and is marketed under the brand name Cimzia.
- It is important to consult a healthcare professional for diagnosis and treatment of PN or eczema.
- More information about nemolizumab and the conditions it treats is available on the GOV UK website.
The AI has provided us with the news.
GOV UK a new article on 2025-02-17 15:32 titled “Nemolizumab approved to treat prurigo nodularis and atopic dermatitis (eczema) for patients in the UK”. Please write a detailed article on this news item, including any relevant information. Answers should be in English.
6