“Sun Pharma’s Leqselvi has a strong chance to see quick patient uptake in the US. The JAK 1/2 inhibitor was approved by the FDA in July 2024 for treatment of adults with severe alopecia areata (AA); however, a patent ruling in November 2024 resulted in an injunction blocking the commercial release of the drug in the US. With the injunction overturned, Leqselvi’s higher dose of 8mg twice daily, positions it in a stronger position compared to Eli Lilly’s Olumiant that is taken at 2mg or 4mg per day for severe AA. The key opinion leaders (KOLs) interviewed by GlobalData believe the higher dose will have a slightly better efficacy in treatment of adults with severe AA.
“Leqselvi’s FDA approval in 2024 drew in lots of excitement from KOLs in the US at that time, as the therapy was directly addressing the current gap in the market for therapies with higher efficacy profiles. Besides, clinicians are increasingly becoming familiar with JAK inhibitors for AA, thanks to precedence set by first-to-market Eli Lilly’s Olumiant FDA approval in 2022, and Pfizer’s Litfulo approval in 2023. Additionally, the use of this drug class in other immunology indications bolster’s its profile in this space. The positive sentiment for JAK inhibitors for AA is now expected to continue as in-class competition intensifies with anticipated launch of Leqslevi in the US.
“While Sun Pharma is yet to disclose launch plans for Leqselvi in the US, the time of launch is anticipated to play a crucial role in this therapy’s success in this market. This is due to the anticipated approval and launch of another JAK inhibitor that is currently in pipeline development: AbbVie’s upadacitinib. GlobalData estimates upadacitinib to launch in the US in 2029 and is likely to have an impact on Leqselvi’s patient share, as the former shares similar mechanism of action as Leqselvi. While results from upadacitinib’s late-stage clinical trials in AA are awaited, its approval and use in other dermatology indications such as atopic dermatitis makes its clinical profile familiar with dermatologists. Additionally, upadacitinib is also being evaluated in adolescent population with severe AA, like Litfulo’s patient profile, implying an advantage of a larger patient population for both these agents.
“While the ongoing litigation between Incyte and Sun Pharma remains, and any future impact of this process remains unknown, the recent injunction overturn may represent an immediate win for Sun Pharma.
“GlobalData’ Alopecia Areata: Opportunity Assessment and Forecast Report reveals that total sales of Leqselvi for alopecia areata is expected to reach $698.3 million in the US by 2033. JAK inhibitors, as a drug-class, will continue to be a mainstay of treatment within this disease space and is anticipated to reach a sales value of $2.0 billion in the US in 2033.”
