Sun Pharma’s LEQSELVI receives FDA approval for severe alopecia areata

INDIA – Indian drugmaker Sun Pharma announced that the U.S. Food and Drug Administration (FDA) has approved LEQSELVI (deuruxolitinib) 8 mg tablets to treat adults with severe alopecia areata.

This new twice-daily oral medication is a selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2, which are believed to play a crucial role in the pathways leading to hair loss in individuals with severe alopecia areata.

The FDA’s approval is grounded in data from two robust multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trials, namely THRIVE-AA1 and THRIVE-AA2.

These trials collectively enrolled 1,220 patients who had experienced at least 50% scalp hair loss, as measured by the Severity of Alopecia Tool (SALT), for a period exceeding six months.

The primary endpoint of the trials was achieved over 24 weeks, with more than 30% of patients treated with LEQSELVI showing 80% or more scalp hair coverage.

Commenting on this approval, Abhay Gandhi, CEO of North America Business at Sun Pharma, highlighted that LEQSELVI offers a new, effective solution that will significantly enhance options for long-suffering patients battling severe alopecia areata and their physicians.

Gandhi also expressed his excitement that this new offering is well-suited to enhance its portfolio in the fast-growing dermatology sector.

Nicole Friedland, President and CEO of the National Alopecia Areata Foundation (NAAF), also welcomed the approval of LEQSELVI, considering it a significant step forward for the alopecia areata community.

She emphasized that LEQSELVI empowers the community with more choices, which NAAF is committed to providing, thereby offering another vital option for those living with severe alopecia areata.

Natasha Mesinkovska, MD, PhD, an investigator in the LEQSELVI clinical development program, noted the critical importance of early intervention with effective treatments for people with severe alopecia areata.

She highlighted that an oral JAK inhibitor delivering proven results will impact the alopecia areata community.

Marek Honczarenko, MD, PhD, Senior Vice President and Head of Development at Sun Pharma, expressed his satisfaction with this development.

He noted that the timely FDA approval of LEQSELVI validates the team’s capability to transition treatments from research and development to approval effectively.

 He also extended his gratitude to all the investigators and patients who participated in the clinical trials.

Alopecia areata is an autoimmune disease that affects approximately 700,000 people in the United States, with around 300,000 experiencing severe forms of the condition.

The disease is characterized by the immune system’s sudden attack on hair follicles, leading to hair loss on the scalp, face, and sometimes other body areas.

The physical, emotional, and financial impacts of alopecia areata extend beyond hair loss, often driving patients to seek self-treatment due to dissatisfaction with the slow progress of existing treatments.

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