FDA Approves Sun Pharma's JAK Inhibitor for Hair Loss

Sun Pharmaceutical Industries has received approval from the US Food and Drug Administration (FDA) for its oral Janus kinase (JAK) inhibitor, Leqselvi (deuruxolitinib), intended to treat severe cases of alopecia areata. Initially developed by Concert Pharmaceuticals, Sun Pharma gained access to Leqselvi following its acquisition of Concert Pharmaceuticals in January 2023 for $576 million.

Alopecia areata is an autoimmune disorder where the immune system attacks hair follicles, causing abrupt and patchy hair loss. JAK inhibitors like Leqselvi function by blocking Janus kinase enzymes, crucial components in inflammation and immune response pathways.

The FDA’s approval of Leqselvi is supported by data from two Phase III clinical trials—THRIVE-AA1 and THRIVE-AA2 (NCT04518995 and NCT04797650). These trials demonstrated that Leqselvi could restore at least 80% of scalp hair coverage in over 30% of participants after 24 weeks of treatment. In total, 1,220 patients with alopecia areata, characterized by at least 50% scalp hair loss for more than six months as measured by the Severity of Alopecia Tool (SALT) scale, were enrolled in these studies.

JAK inhibitors have garnered considerable interest within the field of immunology. Major pharmaceutical companies like Pfizer and AbbVie have secured approvals for their JAK inhibitors, such as Xeljanz (tofacitinib citrate) and Rinvoq (upadacitinib), to treat various conditions including atopic dermatitis, ulcerative colitis, and rheumatoid arthritis.

Alopecia areata, identified as an unmet medical need by professionals, represents a new expansion area for these treatments. In 2022, Eli Lilly’s Olumiant (baricitinib) became the first JAK inhibitor approved by the FDA for alopecia areata. Before this development, patients primarily relied on off-label treatments like local corticosteroid injections. According to Eli Lilly’s financial reports, Olumiant generated $922.6 million in sales in 2023.

In September 2021, the FDA announced that it would require safety warnings for JAK inhibitors following a study in rheumatoid arthritis patients, which indicated an increased risk of cardiovascular events. Like most JAK inhibitors, Leqselvi comes with a boxed warning that highlights potential risks, including serious infections, mortality, malignancies, major adverse cardiovascular events, and thrombosis.

In a statement following the approval, Sun Pharma’s North America CEO Abhay Gandhi remarked: “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.”

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