MHRA authorises Pfizer’s Litfulo for alopecia areata

Litfulo is an enzyme inhibitor therapy in the form of an oral capsule that lowers inflammation and leads to hair regrowth.

Vishnu Priyan November 02 2023

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorisation to Pfizer’s Litfulo (ritlecitinib) to treat severe alopecia areata in people aged 12 and above.

In alopecia areata, the immune system targets the hair follicles, resulting in inflammation and eventual hair loss on the face, scalp and/or other body parts.

Litfulo is an enzyme inhibitor therapy in the form of an oral capsule.

It reduces the activity of the Janus kinase 3 and the tyrosine kinase, both of which are associated with inflammation at the hair follicle.

The product therefore lowers inflammation and leads to hair regrowth.

The MHRA-indicated dosage of the therapy is 50mg once a day. 

Headache, dizziness, diarrhoea, rash, hair follicle inflammation, acne and higher creatine phosphokinase levels are the most frequently reported side effects of Litfulo.

In a media release, the UK Government stated: “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 or by searching the Google Play or Apple stores for MHRA Yellow Card.”

In September 2023, the European Commission granted marketing authorisation to Litfulo for the same indication.

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