FDA to Review Ritlecitinib for Alopecia Areata

The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for ritlecitinib for patients 12 years of age and older with alopecia areata.

Ritlecitinib is an oral covalent kinase inhibitor with high selectivity for Janus kinase 3 (JAK3) and members of the tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family. The NDA includes data from the phase 2b/3 ALLEGRO trial (ClinicalTrials.gov Identifier: NCT03732807) and the ongoing, open-label, long-term phase 3 ALLEGRO-LT study (ClinicalTrials.gov Identifier: NCT04006457).

In the ALLEGRO trial, patients (N=718) were randomly assigned to receive ritlecitinib 30mg or 50mg (with or without 1 month of initial treatment with ritlecitinib 200mg once daily), ritlecitinib 10mg or placebo. The primary endpoint was the proportion of patients with scalp hair regrowth in response to ritlecitinib treatment, based on an absolute Severity of Alopecia Tool (SALT) score of 20 or less at week 24. All participants entered the study with at least 50% scalp hair loss due to alopecia areata.

Compared with placebo, a statistically significantly greater proportion of patients who received ritlecitinib 30mg or 50mg once daily (with or without 1 month of initial treatment of 200mg once daily), had 20% or less scalp hair loss (an absolute SALT score ≤20) after 24 weeks of treatment.  The most common adverse events reported in the study were nasopharyngitis, headache and upper respiratory tract infection.

Data from the long-term study will be presented at the 2022 European Academy of Dermatology and Venereology (EADV) Congress.

“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,” said Michael Corbo, PhD, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. “We believe that ritlecitinib, if approved, will be an important new treatment option, and we are continuing to work closely with regulatory authorities to bring ritlecitinib to adults and adolescents in the US and the EU.”

The FDA is expected to make a decision in the second quarter of 2023.

References

1. FDA and EMA accept regulatory submission for Pfizer’s ritlecitinib for individuals 12 years and older with alopecia areata. News release. September 9, 2022. https://www.businesswire.com/news/home/20220908006121/en/FDA-and-EMA-Accept-Regulatory-Submission-for-Pfizer%E2%80%99s-Ritlecitinib-for-Individuals-12-Years-and-Older-with-Alopecia-Areata
2. Pfizer announces positive top-line results from phase 2b/3 trial of ritlecitinib in alopecia areata. News release. August 4, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-announces-positive-top-line-results-phase-2b3-trial