New drug could restore 80 percent of hair loss in alopecia patients
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A condition marked by severe hair loss from the scalp to the face and body, alopecia areata is a disease that occurs when the immune system attacks hair follicles and causes hair loss, according to the National Institute of Health.
The condition does not have a cure. While there are limited treatments available that help hair grow back faster, severe cases are especially resistant to treatment.
In such cases, a new medication called ritlecitinib has the potential to make a significant impact.
The US Food and Drug Administration (FDA) has approved the new medicine, LITFULO, Pfizer announced last week.
The drug has been developed in the form of an oral pill that is prescribed to be taken once a day. However, only people above the age of 12 who have a hair loss condition called alopecia areata are permitted to consume it.
With LITFULO being the first FDA-approved drug for teenagers suffering from a hair condition, the recommended dose is set at 50mg.
Dr Brittany Craiglow, Associate Professor of Dermatology at Yale School of Medicine says that patients may develop symptoms of alopecia areata at any age but most people start showing signs in their teens, twenties or thirties.
Treatment awareness
“LITFULO is a particularly important treatment option for younger patients with substantial hair loss, who often struggle with such a visible disease,” she said.
The hair loss pill belongs to a group of enzymes called kinase. It functions when the two specific types of proteins are blocked – Janus kinase 3 (JAK3) and the tyrosine kinase expressed in the hepatocellular carcinoma (TEC) family of kinases.
According to National Cancer Institute, human cells are made of different types of kinases, that help control important functions, such as cell signaling, metabolism, division, and survival.
Inhibiting kinase proteins will enable the control of some processes in the body that contribute to hair loss.
According to Pfizer, the FDA approval was based on the results of the clinical trials in treating patients with alopecia areata.
Study components
The study known as ALLEGRO Phase 2b/3 trial was conducted on 718 people suffering from the hair medical condition. All patients experienced scalp hair loss of at least 50 percent or more measured by the Severity of Alopecia Tool (SALT).
Furthermore, they evaluated the efficacy and safety of LITFULO at 118 sites in 18 countries, Pfizer said.
The study came to the conclusion that 23 percent of the patients who were treated with 50 mg of LITFULO recovered at least 80 percent or more scalp hair in the duration of six months as opposed to 1.6 percent recovering through placebo.
“The efficacy and safety of LITFULO were consistent between adolescents (12 through 17 years of age) and adults (18 years of age and older),” Pfizer states.
Additionally, Pfizer reports that the most common adverse events (AEs) registered in at least 4 percent of patients with LITFULO include headache (10.8 percent), diarrhea (10 percent), acne (6.2 percent), rash (5.4 percent), and urticaria (4.6 percent).
Chief Commercial Officer, President, Global Biopharmaceuticals Business, Pfizer, Angela Hwang says that 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.
“With today’s approval, adolescents and adults who struggle with substantial hair loss have an opportunity to achieve significant scalp hair regrowth,” she said.
Complete information from the ALLEGRO Phase 2b/3 study was published by The Lancet in April 2023, and can be viewed here.
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