Sun Pharma’s LEQSELVI Gets FDA Approval

Sun Pharmaceutical Industries Limited has received approval from the U.S. Food and Drug Administration (FDA) for its new drug, LEQSELVI (deuruxolitinib), an oral JAK inhibitor designed to treat severe alopecia areata.

LEQSELVI Approval Details

LEQSELVI is the first oral treatment of its kind for severe alopecia areata, an autoimmune condition causing sudden hair loss on the scalp and other areas. The FDA's approval is based on two multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trials THRIVE-AA1 and THRIVE-AA2 which included 1,220 patients. These trials demonstrated that LEQSELVI significantly improves hair regrowth.

• Clinical Trial Results: At the start of the trials, patients had an average of only 13% scalp hair coverage. By week 24, more than 30% of patients achieved 80% or more scalp hair coverage. About 25% of patients saw nearly full hair regrowth (≥90% coverage).

Data from the trails 

LEQSELVI works as a selective inhibitor of Janus Kinases (JAK1 and JAK2), which are believed to contribute to hair loss in alopecia areata. The drug is administered in 8 mg tablets, taken twice daily. The approval follows promising results that showed LEQSELVI can restore significant hair coverage for many patients.

While LEQSELVI shows effectiveness, it may cause serious side effects such as infections, cancer, blood clots, and gastrointestinal issues. Common side effects observed in clinical trials include headache (12.4%), acne (10%), and nasopharyngitis (8.1%). The drug is not recommended for patients with certain genetic conditions or those on specific medications.

Abhay Gandhi, CEO of North America Business at Sun Pharma, expressed enthusiasm about the approval, noting that LEQSELVI will provide new options for patients with severe alopecia areata. Marek Honczarenko, Senior Vice President at Sun Pharma, said “This validates our team’s capability to effectively bring treatments from research and development to approval in a way that is meaningful for physicians and patients.” 

Nicole Friedland, President and CEO of the National Alopecia Areata Foundation (NAAF), welcomed the approval as a significant advancement, offering the alopecia community a valuable new treatment option.

Sun Pharma’s LEQSELVI is set to become a vital addition to its dermatology portfolio, addressing a critical need for effective treatments in the field of alopecia areata.

Source: Here 

Alopecia Areata

This disorder occurs when the immune system mistakenly targets hair follicles, leading to hair loss.Alopecia areata primarily causes hair loss in small, round patches on the scalp or other parts of the body. While hair loss can vary in severity, most people remain otherwise healthy. 

Alopecia areata is an autoimmune disease affecting around 700,000 people in the United States, with 300,000 experiencing severe forms of the condition that can be unpredictable, with some individuals experiencing recurring hair loss, while others may have only a single episode. Hair regrowth is also variable, with some individuals regaining their hair completely.

Types of Alopecia Areata:

1. Patchy Alopecia Areata: Loss of hair in one or more small patches.
2. Alopecia Totalis: Loss of all or nearly all hair on the scalp.
3. Alopecia Universalis: Rare type where there is a complete loss of hair on the scalp, face, and body.

Alopecia areata affects both men and women across all racial and ethnic groups, with onset commonly in the teens, twenties, or thirties. It can be more extensive and progressive in younger children.

While a family history of the disease can increase risk, many people with alopecia areata have no known family connection. Genetic factors and autoimmune diseases like psoriasis or thyroid conditions may contribute to the risk.

The exact cause of alopecia areata is not fully understood, but it involves the immune system attacking hair follicles. Both genetic and environmental factors are believed to play a role.

Know more about the Disease Here

Sun Pharma

Sun Pharmaceutical Industries Limited is a global leader in specialty generics, with a strong presence in specialty, generics, and consumer healthcare products. As India's largest pharmaceutical company and a top player in the U.S. and emerging markets.

Sun Pharma's high-growth specialty portfolio includes dermatology, ophthalmology, and onco-dermatology, contributing over 18% to its sales. With manufacturing facilities across six continents and a diverse workforce from over 50 countries, Sun Pharma is committed to delivering high-quality medicines trusted worldwide.