Alopecia areata, a condition characterized by sudden hair loss due to the immune system attacking hair follicles, affects both men and women and can involve areas of the body beyond the scalp. Estimates suggest that around 700,000 people in the U.S. suffer from this condition, with 300,000 experiencing what is considered severe alopecia areata. For individuals dealing with this distressing issue, a new FDA-approved treatment offers hope. Sun Pharmaceutical Industries has recently launched a third-in-class drug, deuruxolitinib, set to provide a new treatment option against competing medicines already available from Eli Lilly and Pfizer.
The FDA’s approval of deuruxolitinib, which will be marketed under the brand name Leqselvi, specifically targets adults with severe forms of the condition. Sun Pharma, based in Mumbai, India, with U.S. operations in Princeton, New Jersey, will market this twice-daily oral pill designed as a small molecule inhibitor. Leqselvi works by targeting Janus kinases (JAK), enzymes linked to inflammatory processes in the body. The drug specifically blocks JAK1 and JAK2 proteins, aiming to interrupt pathways that contribute to hair loss in severe alopecia areata cases.
The decision to approve Leqselvi by the FDA was supported by data from two placebo-controlled Phase 3 studies, which surveyed 1,220 patients suffering from significant hair loss due to alopecia areata for more than six months. These studies demonstrated that at 24 weeks, over 30% of participants treated with Leqselvi achieved 80% or more scalp coverage—meeting the main study objective and underscoring the drug’s potential efficacy.
Concerns about possible side effects have been noted, with the most common during trials being headache, acne, and nasopharyngitis. Additionally, Leqselvi’s labeling contains a black box warning, the strictest FDA warning. This alert forewarns both prescribers and patients about risks such as cancer and cardiovascular events—a caution that applies to all JAK inhibitors.
This new drug enters a market where there are already approved JAK inhibitor treatments for severe alopecia areata from pharmaceutical giants Eli Lilly and Pfizer. Eli Lilly’s Olumiant and Pfizer’s Litfulo, both once-daily pills, were approved in the past few years. The need for twice-daily dosing with Leqselvi may place it at a disadvantage compared to these existing treatments, potentially influencing Sun Pharma’s pricing and marketing strategies. Although specific details regarding the pricing of Leqselvi were not disclosed, a Sun Pharma spokesperson emphasized efforts to collaborate with payers to ensure the treatment’s affordability and accessibility in the U.S. The timeline for Leqselvi’s market launch is yet to be confirmed.
Sun Pharma’s addition of Leqselvi to its portfolio was facilitated through its acquisition of the drug’s developer, Concert Pharmaceuticals based in Lexington, Massachusetts. The transaction cost Sun Pharma approximately $576 million, equating to $8 per Concert share, with an additional contingent payment of $3.50 per share pending the achievement of specific sales milestones.
The availability of Leqselvi provides a new therapeutic option for those battling severe alopecia areata, offering them potential relief and improvement in a condition that can significantly affect personal well-being and self-esteem. As the alopecia treatment landscape continues to evolve, the impact of Sun Pharma’s new addition remains to be fully seen, particularly in how it stacks up against established treatments in terms of efficacy, side effects, usage convenience, and cost.
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