source : www.gov.uk
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (November 1, 2023) approved a new medicine called Litfulo (ritlecitinib), an enzyme inhibitor treatment for severe alopecia areata in patients aged 12 years and over.
Alopecia areata is a disease in which the body’s own immune system attacks the hair follicles, causing inflammation that leads to hair loss on the scalp, face and/or other parts of the body.
The active ingredient in this treatment, ritlecitinib, is an enzyme inhibitor. It works by reducing the activity of enzymes in the body called JAK3 and TEC kinases, which are involved in inflammation in the hair follicles. This reduces inflammation, which leads to hair growth in patients with alopecia areata.
Litfulo is a medicine in hard capsules, recommended for oral intake in one dose of 50 mg per day.
The most common side effects of the medicine are headache, diarrhea, dizziness, acne, rash (except hives and shingles), inflammation of the hair follicles which may be itchy or painful, and an increase in an enzyme called creatine phosphokinase, shown in blood tests. test.
As with any medicine, the MHRA will closely monitor the safety and effectiveness of Litfulo. Anyone who suspects they are having a side effect from this medicine should discuss it with their doctor, pharmacist or nurse and report it directly to the Yellow Card scheme either via the website (https://goldencard.mhra.gov.uk/ ) or by searching for MHRA Yellow Card in the Google Play or Apple App stores.
Notes for editors
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in Britain by making sure they work and are acceptably safe. All our work is underpinned by robust and evidence-based judgments to ensure the benefits justify any risks.
The MHRA is an executive agency of the Department of Health and Social Care.
The marketing authorization was granted to Pfizer Ltd on 1 November 2023.
More information can be found in the Summary of Product Characteristics and Patient Information Leaflets, which will be published on the MHRA Products website within seven days of approval.
For more information about alopecia areata see: Alopecia Areata – Alopecia UK
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source : www.gov.uk