Sun Pharma secures FDA approval for alopecia drug Leqselvi

Eli Lilly achieved a significant milestone when Olumiant became the first medication cleared by the FDA for treating alopecia areata, an autoimmune disorder that damages hair follicles. This was soon followed by Pfizer's FDA approval for its JAK inhibitor, Litfulo. Now, about a year after Pfizer's approval, Sun Pharma has entered the field with its own treatment. The FDA recently approved Sun Pharma’s oral JAK inhibitor, deuruxolitinib, now marketed under the brand name Leqselvi, for severe alopecia areata in adults.

Alopecia areata, a prevalent autoimmune disease, affects roughly 700,000 individuals in the United States, with 300,000 experiencing its severe form. This condition leads to hair loss by causing the immune system to attack hair follicles. Patients frequently try to manage their symptoms independently due to dissatisfaction with the slow results from existing treatments.

In addition to specialized drugs like Olumiant, Litfulo, and Leqselvi, patients often resort to oral steroids or topical treatments, which only address specific areas of hair loss. The FDA’s approval of Leqselvi was based on the outcomes of two advanced-stage trials, THRIVE-AA1 and THRIVE-AA2. These studies included 1,220 patients who had experienced at least 50% scalp hair loss for over six months.

Initially, participants in the THRIVE-AA1 and THRIVE-AA2 trials had an average of just 13% scalp hair coverage. After 24 weeks, over 30% of those treated with Leqselvi achieved 80% or more scalp coverage, and up to 25% regained almost full scalp hair coverage by the end of the trials.

While Leqselvi shows promise as a treatment for alopecia areata, it is associated with some significant safety concerns, typical of the JAK inhibitor category. Potential side effects include serious infections, cancers, thrombosis, and gastrointestinal perforations. There is also an elevated risk of death and major cardiovascular incidents.

Sun Pharma expressed its commitment to making Leqselvi available to patients promptly. They plan to provide further information on the drug’s launch timeline soon. Leqselvi was originally developed by Concert Pharmaceuticals, which Sun Pharma acquired for $576 million in January 2023. Following the acquisition, Sun Pharma quickly aimed to secure FDA approval for deuruxolitinib, confident in their ability to market the drug globally.

In May 2022, Concert announced favorable phase 3 trial results for its JAK inhibitor, leading analysts at Mizuho Securities to suggest it could outperform both Lilly and Pfizer's products in terms of efficacy. Sun Pharma's recent FDA approval comes just over two years after Lilly and Incyte's Olumiant became the first FDA-approved treatment for alopecia areata in adults. Initially approved in 2018 for severe rheumatoid arthritis, Olumiant paved the way for subsequent treatments.

A year after Olumiant’s approval for alopecia, Pfizer received FDA clearance for Litfulo, also known as ritlecitinib. Unlike Olumiant and Leqselvi, Litfulo is approved for use in both adults and children over 12, potentially giving it a competitive edge.

In conclusion, the recent FDA approval of Sun Pharma’s Leqselvi marks another advancement in the treatment options available for alopecia areata, providing new hope for patients suffering from this challenging condition.

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