Pfizer Reports the US FDA and EMA's Acceptance of NDA & MAA for Ritlecitinib to Treat Alopecia Areata in Patients Aged ≥12 Years
Shots:
- The US FDA has accepted NDA for ritlecitinib in adults and adolescents aged ≥12yrs. with alopecia areata with an expected decision in Q2’23. The EMA has also accepted the MAA for ritlecitinib with an expected decision in Q4’23
- The submissions were based on the P-IIb/III (ALLEGRO) study & an ongoing P-III (ALLEGRO-LT) study to evaluate ritlecitinib in 718 & 1050 adults & adolescents aged ≥12yrs. with AA
- The results from the P-IIb/III (ALLEGRO) study showed that patients achieved ≥80% scalp hair coverage after 6mos. of treatment over PBO. The safety results were well tolerated, AEs & SAEs (82% and 2%) with similar rates across active treatment groups. The company has completed regulatory submissions in the UK, China & Japan with an expected decision in 2023
Ref: Buisnesswire | Image: Pfizer
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