After Eli Lilly’s Olumiant won the distinction of becoming the first med approved by the FDA to treat the follicle-attacking autoimmune disease alopecia areata, Pfizer followed up with a green light for its own JAK inhibitor, Litfulo, the following year.
Now, a little more than 12 months after Pfizer’s green light, Sun Pharma is getting in on the action, too.
Thursday, the FDA signed off (PDF) on Sun’s oral JAK inhibitor deuruxolitinib to treat adults with severe alopecia areata. The drug is now approved in 8-mg tablets under the brand name Leqselvi, Sun said in a release.
Alopecia areata is a common autoimmune disease that affects around 700,000 people in the United States, 300,000 of whom have the severe form of the disease, according to Sun. Alopecia causes hair loss, which is thought to occur because of the collapse of immune privilege, leading patients' immune systems to target their hair follicles.
Alopecia often prompts patients to self-treat before seeking professional help, thanks in large part to dissatisfaction with the “slow progression” of existing treatments, Sun added.
Aside from targeted drugs like Olumiant, Litfulo and Leqselvi, alopecia patients may also take oral steroids or topical medications, which only target certain affected parts of the body.
The FDA issued its positive decision for Leqselvi on the back of two late-stage studies, THRIVE-AA1 and THRIVE-AA2, which enrolled a total of 1,220 patients who had at least 50% scalp hair loss for more than six months, as measured by a common metric of alopecia severity.
At the start of THRIVE-AA1 and THRIVE-AA2, patients had only 13% of scalp hair coverage on average. At the 24-week mark, more than 30% of patients on Leqselvi saw their scalp coverage swell to 80% or more. What’s more, up to 25% of patients had almost all of their scalp hair back at the end of the trials, Sun said.
While Leqselvi offers a promising solution for alopecia areata patients, the drug does come with some formidable safety setbacks, which are common to the JAK inhibitor class writ large. Leqselvi has the potential to cause side effects ranging from serious infections and cancers to thrombosis and gastrointestinal perforations, according to Sun’s release. The company also flagged the potential for an increased risk of death and major cardiovascular events.
In an emailed statement, a Sun Pharma spokesperson said the company’s priority is to deliver Leqselvi to patients “as soon as possible.” The company said it would soon provide additional updates on launch timing.
Leqselvi started development under Concert Pharmaceuticals, which Sun purchased for $576 million in January 2023. Upon completing the acquisition, Sun stated that its immediate focus would be to submit a new drug application to the FDA for deuruxolitinib. At the time, the Indian company said it was “well positioned to successfully bring this product to market globally.”
Back when Concert rolled out positive phase 3 data on its JAK inhibitor in May, 2022, analysts at Mizuho securities opined that the company could have best-in-class efficacy over Lilly and Pfizer’s offerings.
Sun’s approval comes a little more than two years after Lilly and Incyte’s Olumiant became the first drug specifically approved by the FDA to treat adults with alopecia. Olumiant was originally approved in 2018 to treat severely active rheumatoid arthritis.
A year after Lilly’s nod, Pfizer followed suit with an approval for its once-daily JAK inhibitor Litfulo, also known as ritlecitinib. Notably, Pfizer’s med was cleared for use in both adults and kids over the age of 12, giving it a potential advantage over both Lilly and Sun’s offerings.