2024-09-19 09:57:00
Pfizer: AIFA grants reimbursement authorization for Litfulo (ritlecitinib), an indicated treatment for Alopecia Areata
L’Italian Pharmaceutical Company (AIFA) has authorized reimbursement for Ritlecitinibtreatment is indicatedsevere alopecia areata (SALT score ≥50) in adults and adolescents 12 years of age and older who are candidates for systemic therapy and who have responded poorly to or are intolerant to alternative treatment options or for whom no other treatment option is appropriate.
Refund policy for Ritlecitinib established by the AIFA resolution published at Journal It works last September 17 (GU n.218 170924). The drug, in class H, in the form of hard capsule 50 mg for oral administration, is subject to a limited medical prescription, to be renewed from time to time, by hospitals or specialists – dermatologists and pediatric specialist.
Ritlecitinibalready authorized in Europe byEuropean Medicines Agency (EMA) on September 15, 2023, works by reducing the activity of enzymes called JAK3 and TEC kinases involved in the inflammation of the hair follicle. This reduces inflammation, hair growth and hair regeneration in patients with alopecia areata.
As reported by EMAThe approval process is based on an initial survey 718 adults and youth over 12 years old with severe alopecia areata, 261 were treated with 50 mg of ritlecitinib or placebo. All patients had more than 50% hair loss before starting treatment. After 24 weeks of treatment, symptoms improved in patients treated with ritlecitinib: 13% of them were close to remission, meaning they had more than 90% skin coverage, and 23% in more than 90% of the area. Such improvements were observed in 1.5% of patients treated with placebo.
After 48 weeks31% of patients treated with the drug are close to remission. When asked if their alopecia had improved, 49 percent of patients treated with ritlecitinib said their condition was moderate or better, compared with 9 percent of patients who received placebo.
L’alopecia areata is an autoimmune disease characterized by patchy or complete loss of hair on the scalp or hair on the face and/or other body parts. The disease has an immune-inflammatory origin and develops when the immune system attacks the hair follicles, causing hair loss. Alopecia areata affects approx 2% of the population, without distinction of age, sex, or race, and causes considerable psychosocial halo in each affected.
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