Concert Pharmaceuticals, Inc.

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. 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. 

Sun Pharmaceutical announced that the FDA cleared the oral JAK 1/2 inhibitor Leqselvi (deuruxolitinib) to treat severe alopecia areata in adults. The drug, which will be available as an 8 mg tablet for twice-daily dosing, was added to the company’s portfolio through its buyout of Concert Pharmaceuticals early last year."Leqselvi offers a new and effective solution…for long-suffering patients battling severe alopecia areata and their physicians," said Abhay Gandhi, chief executive of the company’s North America unit. Not the only JAKHowever, being the third oral JAK inhibitor for severe alopecia, Leqselvi will take on Eli Lilly and Incyte's JAK1/2 inhibitor Olumiant (baricitinib), cleared by the FDA in 2022, and Pfizer's once-weekly JAK3 inhibitor Litfulo (ritlecitinib), which became the first therapy approved for adolescents with the condition last year. The approval of Leqselvi is backed by two Phase III studies, THRIVE-AA1 and THRIVE-AA2, involving 1220 patients with alopecia areata having at least 50% scalp hair loss for over six months, as per Severity of Alopecia Tool (SALT). Results showed that at 24 weeks, over 30% of patients receiving Leqselvi achieved the primary endpoint of ≥80% scalp hair coverage (SALT ≤20). Moreover, the number of patients reaching a SALT score of ≤20 consistently increased through 24 weeks without plateauing. Additionally, up to a quarter of patients regained ≥90% of their scalp hair by week 24. Boxed warningSun Pharma noted that Leqselvi's label carries a boxed warning highlighting the risk of serious side effects such as infections, malignancies, thrombosis, gastrointestinal perforations and laboratory abnormalities, alongside increased risks for mortality and major cardiovascular events.Leqselvi hit a minor snag last May after the FDA put a partial clinical hold on the 12-mg dose due to the potential for thrombotic events. At the time, Sun noted there were no instances of thrombosis for the drug’s 8-mg dose, which was the only dose submitted and subsequently accepted for review by the agency in October.

Alopecia areata occurs when the immune system attacks hair follicles and causes hair loss. Credit: Brester Irina via Shutterstock. Sun Pharmaceutical Industries has secured the US Food and Drug Administration (FDA) approval for its oral Janus kinase (JAK) Inhibitor Leqselvi (deuruxolitinib) to treat severe alopecia areata. Originally developed by Concert Pharmaceuticals , Sun Pharma inherited the asset when it purchased Concert Pharmaceuticals in January 2023 for $576m. Alopecia areata is an autoimmune condition where the immune system attacks hair follicles, leading to sudden, patchy hair loss. JAK inhibitors such as Leqselvi block the activity of Janus kinase enzymes, which are involved in the signalling pathways that drive inflammation and immune responses. The FDA approval is based on data gathered from two Phase III studies—THRIVE-AA1 and THRIVE-AA2 (NCT04518995 and NCT04797650)—where Leqselvi restored scalp hair coverage by at least 80% in more than 30% of patients after 24 weeks. The 1,220 patients enrolled across the two studies had alopecia areata with at least 50% scalp hair loss as measured by Severity of Alopecia Tool (SALT) scale for more than six months. JAK inhibitors have gained significant attention in the immunology space. Pharma giants such as Pfizer and AbbVie stacked up on approvals in indications such as atopic dermatitis, ulcerative colitis, and rheumatoid arthritis with their blockbuster JAK inhibitors Xeljanz (tofacitinib citrate) and Rinvoq (upadacitinib), respectively. See Also: FDA approves Sun Pharma’s JAK inhibitor for alopecia Bavarian Nordic wins positive CHMP opinion to amend Imvanex approval Alopecia areata , which was highlighted as an unmet need by professionals in the space, is now another area of expansion. Eli Lilly’s Olumiant (baricitinib) bagged an FDA approval in this space in 2022, making it the first approved JAK inhibitor to treat the condition. Before this, patients would seek local corticosteroid injections as off label treatments. Olumiant pulled in $922.6m in sales for Lilly in 2023, as per the company’s financials. In September 2021, the FDA said it will require safety warnings for JAK inhibitors after a study in rheumatoid arthritis patients showed an increased risk of cardiovascular events. Similar to most other JAK inhibitors, Leqselvi comes with a boxed warning for serious infections, mortality, malignancies, major adverse cardiovascular events, and thrombosis. In the announcement accompanying the approval, Sun Pharma’s North America CEO Abhay Gandhi said: “Leqselvi offers a new and effective solution that will significantly enhance options for long-suffering patients battling severe alopecia areata and their physicians. Our fast-growing dermatology business is excited to add this novel treatment to its portfolio.” According to GlobalData’s Pharma Intelligence Center, Leqselvi is forecast to generate $253m in 2030. GlobalData is the parent company of Pharmaceutical Technology.