ALLEGRO

European Commission Approves Pfizer’s LITFULO™ for Adolescents and Adults With Severe Alopecia Areata

Retrieved on: 
Dienstag, September 19, 2023
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Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for LITFULO™ (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) today announced that the European Commission (EC) has granted marketing authorization for LITFULO™ (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata.
  • LITFULO, a once-daily oral capsule, is the first medicine authorized by the EC to treat individuals as young as 12 years of age with severe alopecia areata.
  • 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.
  • ALLEGRO-LT (NCT04006457) is an ongoing Phase 3, open-label, long-term study, with safety and efficacy data being collected for adults with alopecia areata with 25% or greater scalp hair loss and adolescents from 12 years of age with alopecia areata with 50% or greater scalp hair loss.

FDA Approves Pfizer’s LITFULO™ (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata

Retrieved on: 
Freitag, Juni 23, 2023
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It is the first and only treatment approved by the FDA for adolescents (12+) with severe alopecia areata.

Key Points: 
  • It is the first and only treatment approved by the FDA for adolescents (12+) with severe alopecia areata.
  • “LITFULO is an important treatment advancement for alopecia areata, an autoimmune disease that previously had no FDA-approved options for adolescents and limited options available for adults,” said Angela Hwang, Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer.
  • “With today’s approval, adolescents and adults who struggle with substantial hair loss have an opportunity to achieve significant scalp hair regrowth.”
    The FDA approval was based on results of clinical trials in alopecia areata.
  • “We believe the approval of LITFULO is a significant advancement for the treatment of alopecia areata, particularly for teens.

FDA and EMA Accept Regulatory Submission for Pfizer’s Ritlecitinib for Individuals 12 Years and Older with Alopecia Areata

Retrieved on: 
Freitag, September 9, 2022
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Alopecia areata affects approximately 6.8 million people in the U.S. and around 147 million people globally.

Key Points: 
  • Alopecia areata affects approximately 6.8 million people in the U.S. and around 147 million people globally.
  • Pfizer has also completed regulatory submissions for ritlecitinib in the United Kingdom, China and Japan, and expects decisions in 2023.
  • The randomized, placebo-controlled, double-blind ALLEGRO Phase 2b/3 study investigated ritlecitinib in patients 12 years of age and older with alopecia areata (n=718).
  • Alopecia areata is an autoimmune disease that has underlying immuno-inflammatory pathogenesis and targets hair follicles, which results in hair loss.