GovWire

The Medicines and Healthcare products Regulatory Agency (MHRA) has today (1 November 2023) authorised a new medicine called Litfulo (ritlecitinib), an enzyme inhibitor treatment for severe alopecia areata in patients 12 years and older.

Alopecia areata is a disease where the bodys own immune system attacks 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 at the hair follicle. This reduces the inflammation, leading to hair regrowth in patients with alopecia areata.

Litfulo is a hard capsule medicine, recommended to be taken in one 50mg dose a day by mouth.

The most common side effects of the medicine are headache, diarrhoea, dizziness, acne, rash (other than hives and shingles), inflammation of the hair follicles that may be itchy or painful and an increase in an enzyme called creatine phosphokinase, shown by blood test.

As with any medicine, the MHRA will keep the safety and effectiveness of Litfulo under close review. Anyone who suspects they are having a side effect from this medicine should 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.

Notes to editors?

• 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.?

• The Marketing Authorisation was granted on 1 November 2023 to Pfizer Ltd.

• 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 7 days of approval.

• For more information on alopecia areata see: Alopecia Areata - Alopecia UK

• For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 020 3080 7651 (Mon-Fri 08:30-17:00) or 07770 446 189 (outside off

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