On 23 June 2023, the US Food and Drug Administration (FDA) approved ritlecitinib (brand name Litfulo) for the treatment of severe alopecia areata, marking the second FDA-approved treatment for the condition in adults, and the first for children ages 12 and up.  

Ritlecitinib belongs to a class of medications known as Janus Kinase (JAK) inhibitors. A different JAK inhibitor, baricitinib, was approved by the FDA last year and is currently still under consultation with the National Institute for Health Care and Excellence (NICE) following the acceptance of several appeal points raised by Alopecia UK. You can read our update about baricitinib here.  

For drugs to be approved for use in the UK by the NHS, they need to be approved by NICE. The expected date for NICE to publish their advice on ritlecitinib as a treatment for severe alopecia areata in people aged 12 years and over is 15 November 2023. Please note that this date is not set in stone and, as we have seen with the baricitinib consultation, timescales can change.  

Alopecia UK is a stakeholder in the NICE consultation and will advocate strongly for this new treatment to be made available, as we have done in the baricitinib consultation. Alopecia UK will attend a NICE appraisal meeting on 5 September 2023. 

It is the pharmaceutical company, in this case Pfizer, who will need to demonstrate that the drug is effective for hair regrowth and improves quality of life, using evidence from their clinical trials. Pfizer will also need to provide health and economic data showing the benefits and safety of the drug for NICE to consider in their recommendations. For anyone interested in reading more about clinical trial data, you can find a summary of clinical trial data for ritlecitinib here

Alopecia UK is not a decision-maker in whether NICE approves ritlecitinib for the treatment of alopecia areata. We are, however, a stakeholder in the consultation process. NICE are listening to our ‘patient voice’ and are taking our advocacy for the importance of wider treatment options seriously.  

We will continue to do what we can. Please know, that as well as Alopecia UK, many of the UK’s leading dermatologists specialising in hair loss are also advocating on your behalf for new treatments to be made available in the UK. 

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