MHRA authorises alopecia treatment

The Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Pfizer’s Litfulo (ritlecitinib) for treatment for severe alopecia areata in patients 12 years and older.

A hard capsule medicine, Litfulo is recommended to be taken daily as one 50mg oral dose .

Litfulo’s active ingredient, ritlecitinib, is an enzyme inhibitor. It works irreversibly and selectively inhibits Janus kinase 3  (JAK3) and the tyrosine (TEC) family of kinases by blocking γ-common cytokine signalling and reducing cytolytic activity of NK and CD8+ cells. This decreases the activity of parts of the immune system that are involved in the inflammation of hair follicles that causes hair loss in people with alopecia areata.

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

UK approval of Litfulo follows Europe and US

The MHRA authorisation follows approval by the European Medicines Agency (EMA) in September and by the US Food and Drug Administration (FDA) in July 2023.

EMA’s approval of Litfulo was based on the ALLEGRO clinical trial programme, which included the Phase IIb/III study (NCT03732807), which enrolled 718 patients with 50 percent or more scalp hair loss as measured by the Severity of Alopecia Tool (SALT) at 118 sites in 18 countries.  Results from this pivotal study showed that 13.4 percent of adults and adolescents saw 90 percent or more scalp hair coverage (SALT ≤10) after 24 weeks of treatment with 50mg of Litfulo compared to 1.5 percent with placebo.

Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer hailed approval of Litfulo as an important milestone, noting that: “Previously, there were no treatment options approved by the EC for adolescents with severe alopecia areata.”

Alopecia areata is a disease where the body’s own immune system attacks hair follicles, causing inflammation that leads to hair loss on the scalp, face and/or other parts of the body. Impacting approximately 2 percent of the population at some point during their lifetime, alopecia areata can affect people of any age, gender, race, or ethnicity and can cause considerable burden beyond hair loss.