Pfizer’s Litfulo (ritlecitinib) has been approved by the US Food and Drug Administration (FDA) as the first treatment option for patients aged 12 years and older with severe alopecia areata.

Affecting almost seven million people in the US and approximately 147 million people globally, alopecia areata is an autoimmune disease characterised by patchy or complete hair loss on the scalp, face, or body.

The condition can develop at any age, with nearly 20% of patients diagnosed before the age of 18.

Litfulo, which is a one-daily oral kinase inhibitor, is thought to work by blocking the activity of signalling molecules and immune cells believed to contribute to the loss of hair in patients with alopecia areata.

Angela Hwang, chief commercial officer, president, Global Biopharmaceuticals Business, Pfizer, said: “Litfulo is an important treatment advancement for alopecia areata, an autoimmune disease that previously had no FDA-approved options for adolescents and limited options available for adults.

“With today’s approval, adolescents and adults who struggle with substantial hair loss have an opportunity to achieve significant scalp hair regrowth.”

The US approval of the drug was supported by positive results from the phase 2b/3 ALLEGRO trial, which enrolled 718 patients with 50% or more scalp hair loss.

In the study, 23% of patients treated with Litfulo 50mg had 80% or more scalp hair coverage after six months, compared to 1.6% in the placebo group, with efficacy and safety results consistent between adolescent and adult patients.

Commenting on the FDA’s decision, president and chief executive officer of the National Alopecia Areata Foundation, Nicole Friedland, said: “People living with alopecia areata are often misunderstood, and their experience is frequently trivialised as ‘just hair.’ However, it is a serious autoimmune disease that can have considerable negative impact beyond the physical symptoms.

“We believe the approval of Litfulo is a significant advancement for the treatment of alopecia areata, particularly for teens. It’s exciting to see more FDA-approved treatments becoming available for this community.”

Litfulo will be available in the coming weeks, Pfizer outlined, adding that regulatory applications for the drug in alopecia areata have already been submitted to countries around the world for review, including the EU, UK and Japan.

Reference：
https://www.pmlive.com/pharma_news/pfizers_litfulo_approved_by_fda_as_first_treatment_for_adolescents_with_severe_alopecia_areata_1493847