On the heels of Eli Lilly’s landmark approval last summer, Pfizer is stepping up to the plate in alopecia areata—and it’s coming equipped with an adolescent nod to put the pressure on Olumiant.
Late last week, the FDA gave a green light to Pfizer’s once daily oral JAK inhibitor ritlecitinib—now christened Litfulo—in adults and children ages 12 and over with severe alopecia areata. Lilly’s rival JAK Olumiant, which became the first med FDA specifically approved for alopecia in June 2022, is only cleared for use in adults.
Patients with alopecia may also take oral steroids or topical medications, which only target certain affected parts of the body.
Pfizer’s drug will cost about $49,000 a year before discounts, according to a company spokesperson. That puts the immunology newcomer’s price tag on par with Olumiant, which runs for $2,622 for a 30-day supply of 2-mg tablets, or $5,244 for a month’s worth of 4-mg tablets.
Aside from inhibiting the janus kinase 3 protein, Litfulo also works by blocking the tyrosine kinase expressed in hepatocellular carcinoma family of kinases, Pfizer explained in a press release.
The FDA’s approval hinges on Pfizer’s phase 2b/3 study ALLEGRO, which looked at 718 patients suffering from 50% or more scalp hair loss according to the Severity of Alopecia Tool. According to the trial, 23% of patients on 50 mg of Litfulo achieved 80% or more scalp hair coverage after six months versus a scant 1.6% on placebo. Safety and efficacy were consistent between teens and adults, with the most common side effects including headache, diarrhea, acne, rash and urticaria.
“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,” Angela Hwang, Pfizer’s chief commercial officer and president of the company’s global biopharma business, said in a statement.
“With today’s approval, adolescents and adults who struggle with substantial hair loss have an opportunity to achieve significant scalp hair regrowth.”
Litfulo, which Pfizer plans to release “in the coming weeks,” is set to tussle with Eli Lilly’s immunology star Olumiant. Almost a year ago to the month, Olumiant—first approved in 2018 for severely active rheumatoid arthritis and more recently cleared for COVID-19 treatment in certain hospitalized adults—bagged its alopecia areata nod, making it the first drug approved for the autoimmune disorder.
The disease causes the body to attack its own hair follicles, which leads hair to fall out. While hair loss most often occurs on the scalp, alopecia can also affect the eyebrows, eyelashes, facial hair and other areas of the body.
Alopecia came to national attention last year following Will Smith’s now infamous Oscars slap over a jab at his wife, Jada Pinkett Smith, who suffers from the condition.
The condition affects nearly 7 million people in the U.S. and roughly 147 million people around the globe, according to Pfizer. Nearly 20% of people with alopecia are diagnosed before the age of 18.