The US Food and Drug Administration (FDA) has recently granted approval for the use of a daily oral drug in individuals aged 12 and above who suffer from severe alopecia areata, an autoimmune condition characterized by significant hair loss, as per a news release from Pfizer.
The findings from a recent double-blind clinical trial indicate that the drug could potentially reverse hair loss in certain patients when taken consistently over several months. The promising results observed in the trial played a pivotal role in securing the FDA's approval for this medication.
FDA Approves First Treatment for Severe Alopecia Areata in Adolescents, Offering Hope for Reversing Hair Loss
New Pfizer Drug Reversed Up to 80% Hair Loss
Alopecia is an autoimmune condition characterized by hair loss on the scalp, face, or body, often causing emotional distress. Severe cases, like alopecia universalis, have limited treatment options, but a new drug called ritlecitinib shows promise in reversing hair loss.
Clinical trials of the new Pfizer drug, called ritlecitinib, demonstrated that the oral medication could reverse up to 80% of scalp hair loss in nearly a quarter of patients, making it one of the few effective and well-tolerated treatments for severe alopecia.
Notably, it is also approved as the only treatment available for children. Another oral drug, baricitinib, was approved in 2022 and is effective in around 20% of cases but is exclusively for adults.
In a recent clinical trial involving over 700 alopecia patients from 18 countries, participants with hair loss on half their scalp for less than ten years were enrolled. Half of the cohort experienced total scalp hair loss.
According to Science Alert, patients who took a daily dose of 50 milligrams of ritlecitinib showed significant hair regrowth compared to those who received a placebo. After six months, approximately 23 percent of the treated group achieved 80 percent or more scalp hair coverage, while only 1.6 percent of the placebo group did.
The duration of the disease seemed to impact outcomes, with better results observed in patients with shorter disease duration, suggesting that the drug is most effective in the early stages of alopecia flare-ups.
The findings of the study, titled "Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomised, double-blind, multicentre, phase 2b-3 trial" published in The Lancet, provide hope for individuals with severe alopecia, as ritlecitinib demonstrates efficacy in reversing hair loss and offers a well-tolerated treatment option, particularly when administered early in the course of the disease.
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How the Drug Works
The precise mechanism by which the drug, sold as LITFULO, reverses hair loss and promotes hair growth is not fully understood. But as per Science Alert, research suggests that it reduces the overactive immune response responsible for attacking the hair follicles.
In studies using mouse models and scalp biopsies, the drug appears to inhibit a specific signaling pathway in immune cells that triggers inflammation in the hair follicle.
The observed regrowth of hair in clinical trials indicates the potential restoration of these hair follicles, possibly by reestablishing their "immune privileges." However, this mechanism of action can also affect the normal functioning of the immune system, making patients on LITFULO more susceptible to infections and illnesses.
In the current clinical trial, the reported side effects were considered minimal and manageable. Angela Hwang, Pfizer's chief commercial officer, emphasizes in the news release the significance of LITFULO as a treatment advancement for alopecia areata, a previously lacking FDA-approved option for adolescents and offering limited options for adults. The approval of LITFULO provides an opportunity for significant scalp hair regrowth for adolescents and adults dealing with substantial hair loss.
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