Pfizer’s Litfulo (ritlecitinib) Receives the US FDA’s Approval for Adults and Adolescents with Severe Alopecia Areata
Shots:
- The approval was based on the P-IIb/III trial (ALLEGRO) evaluating Litfulo vs PBO in 718 patients aged 12yrs. with ≥50% scalp hair loss as measured SALT at 118 sites in 18 countries. Patients initially assigned to PBO switched to Litfulo (50 or 200mg loading dose + 50mg) for an additional 24wks.
- The results showed that 23% vs 1.6% treated with Litfulo (50mg) had ≥80% scalp hair coverage (SALT≤20) after 6mos. The efficacy & safety of Litfulo were consistent b/w adolescents (12-17yrs.) & adults (≥18yrs.), AEs reported in 4% & the results were published in The Lancet
- The EMA has accepted the MAA for ritlecitinib with an expected decision in Q3’23. Litfulo will be available in the coming weeks & is being studied for vitiligo, CD & UC
Ref: Pfizer | Image: Pfizer
Related News:- Pfizer Reports the US FDA and EMA's Acceptance of NDA & MAA for Ritlecitinib to Treat Alopecia Areata in Patients Aged ≥12 Years
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