HQ Team
September 19, 2023: The European Commission granted Pfizer Inc., a marketing authorisation for its once-daily oral capsule to treat hair loss or alopecia aerate.
The medicine, Litfulo, is the first such authorised by the EC to treat adults and individuals from 12 years of age with the autoimmune disease, according to a Pfizer statement.
Alopecia areata is an autoimmune disease characterized by patchy or complete hair loss on the scalp, face, or body.
The disease has an underlying immuno-inflammatory pathogenesis and develops when the immune system attacks the body’s hair follicles, causing hair to fall out.
Valid in all 27 states
“Today’s approval of Litfulo in Europe is an important milestone for patients as young as 12 years of age with substantial hair loss from alopecia areata, as they now have an opportunity to achieve significant hair regrowth,” said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business at Pfizer.
The marketing authorization for Litfulo is valid in all 27 EU member states, and in Iceland, Liechtenstein, and Norway.
The EU approval authorization follows the recommendation for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use in July 2023.
It also follows approvals by the USFDA and the Japanese Ministry of Health, Labour and Welfare in June 2023.
The approval was based on a clinical trial program, which included the final stage that investigated the drug in patients 12 years of age and older with alopecia areata with 50% or more scalp hair loss.
Total body hair loss
It also included patients with alopecia totalis (total scalp hair loss) and alopecia universalis (total body hair loss).
Results from this study showed that 13.4% of adults and adolescents saw 90% or more scalp hair coverage after 24 weeks of treatment with Litfulo compared to 1.5% with placebo.
At week 24, 49.2% of participants reported a response of “moderate” to “great” improvement in their alopecia areata compared to 9.2% with placebo.
“Long-term efficacy and safety data from this study were included in the submission to support the approval,” according to the statement.
Urticaria, acne
The most common adverse reactions reported were diarrhea, acne, upper respiratory tract infections, urticaria, rash, folliculitis, and dizziness.
Impacting approximately 2% 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.
There is an increased risk of death in people, 50 years and older, who have at least one heart disease risk factor and are taking a Janus kinase (JAK) inhibitor. Litfulo is a kinase inhibitor.
