USFDA approval granted for drug against Baldness

The USFDA approval of Leqselvi was based on robust clinical data from two large-scale Phase 3 trials involving over 1,200 patients with severe alopecia areata.

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USFDA Approval
USFDA Approval

Last Updated on October 6, 2024 by The Health Master

USFDA approval

Sun Pharmaceutical Industries Ltd. has made a significant stride in the treatment of hair loss with the US Food and Drug Administration approval (USFDA approval) of Leqselvi (deuruxolitinib) tablets.

This groundbreaking medication is specifically designed to address severe alopecia areata, an autoimmune condition that causes patchy or complete baldness.

Understanding Alopecia Areata

Alopecia areata, a distressing condition affecting approximately 2.5% of the US population, occurs when the immune system mistakenly attacks hair follicles.

This leads to hair loss on the scalp and sometimes other parts of the body.

Until now, treatment options for this autoimmune disorder have been limited, leaving many patients seeking effective solutions.

Leqselvi: A New Hope

Leqselvi, an oral medication, works by inhibiting Janus Kinases (JAK) 1 and JAK2, enzymes involved in immune responses.

By targeting these specific enzymes, the drug helps to regulate the immune system and promote hair regrowth.

Sun Pharma’s CEO of North America Business, Abhay Gandhi, expressed enthusiasm about thedrug’s potential, stating that preparations for commercialization were already underway.

With Leqselvi, Sun Pharma aims to expand its global specialty business, which recently surpassed the $1 billion sales mark.

Clinical Trials Demonstrate Effectiveness

The USFDA approval of Leqselvi was based on robust clinical data from two large-scale Phase 3 trials involving over 1,200 patients with severe alopecia areata.

These trials demonstrated that a significant number of patients who took Leqselvi experienced substantial hair regrowth within 24 weeks.

In fact, up to 25% of participants achieved almost complete hair restoration.

A Promising Future

The USFDA approval of Leqselvi marks a significant milestone in the treatment of alopecia areata.

This innovative medication offers new hope for patients who have long struggled with hair loss.

Sun Pharma’s commitment to developing effective therapies for dermatological conditions is evident with the addition of Leqselvi to its portfolio.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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