FDA, EMA Accept Submissions for Alopecia Therapy

The FDA is expected to make a decision on Pfizer’s ritlecitinib in the second quarter of 2023.

The FDA has accepted for Pfizer’s new drug application (NDA) for ritlecitinib for adults and adolescents 12 years of age and older with alopecia areata. The FDA is expected to make a decision in the second-quarter 2023. Additionally, the European Medicines Agency (EMA) has also accepted the marketing authorization application (MAA) for ritlecitinib in the same patient population with a decision anticipated in the fourth-quarter 2023.

Alopecia areata is an autoimmune disease where the immune system attacks the body’s hair follicles, causing hair to fall out. This hair loss often occurs on the scalp, but it can also affect eyebrows, eyelashes, facial hair and other areas of the body. Alopecia areata affects about 6.8 million people in the United States and around 147 million people globally.

Ritlecitinib is an investigational oral, once-daily treatment that is the first in a new class of oral highly selective kinase inhibitors that is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3 (JAK3).

“Alopecia areata is an autoimmune disease that can impact people of all ages, genders, and ethnicities, often having an impact on day-to-day life that goes beyond the hair loss itself,” Michael Corbo, Ph.D., chief development officer, Inflammation & Immunology, Pfizer Global Product Development, said in a press release.

The submissions were based on the pivotal and dose-ranging phase 2b/3 ALLEGRO study and the ongoing phase 3 ALLEGRO-LT study. In the ALLEGRO study, ritlecitinib met the primary endpoint for improving scalp hair regrowth. All participants entered the study with at least 50% scalp hair loss due to alopecia areata, as measured by the Severity of Alopecia Tool score. A statistically significantly greater proportion of patients who took ritlecitinib 30 mg or 50 mg once-daily had 20% or less scalp hair loss after 24 weeks of treatment compared with placebo.

The most common AEs seen in the study were nasopharyngitis, headache and upper respiratory tract infection. There were no major adverse cardiac events (MACE), deaths or opportunistic infections in the trial.

Pfizer has also completed regulatory submissions for ritlecitinib in the United Kingdom, China and Japan, and expects decisions in 2023.

Ritlecitinib, which has granted breakthrough therapy designation from the FDA for the treatment of alopecia areata, is also being evaluated for vitiligo, rheumatoid arthritis, Crohn’s disease and ulcerative colitis.