FDA Approves Leqselvi for Severe Alopecia

Follow Drugslib on

Medically reviewed by Drugs.com.

By Lori Solomon HealthDay Reporter

FRIDAY, Aug. 2, 2024 -- The U.S. Food and Drug Administration has approved Leqselvi (deuruxolitinib) tablets for the treatment of adults with severe alopecia areata.

Leqselvi (8 mg) is a twice-daily oral selective inhibitor of the Janus kinases JAK1 and JAK2. In trials, the three most common adverse events were headache, acne, and nasopharyngitis.

The approval was based on data from the THRIVE-AA1 and THRIVE-AA2 randomized, double-blind, placebo-controlled phase 3 clinical trials, which enrolled a total of 1,220 patients with alopecia areata who had at least 50 percent scalp hair loss for more than six months. Over 24 weeks, more than 30 percent of patients taking Leqselvi experienced ≥80 percent scalp hair coverage (Severity of Alopecia Tool [SALT] ≤20). Up to one-quarter of patients had almost all of their scalp hair back at 24 weeks (≥90 percent coverage). The number of Leqselvi-treated patients achieving a SALT score ≤20 did not plateau through 24 weeks.

"For many people with severe alopecia areata, early intervention with effective treatment is critical," Natasha Mesinkovska, M.D., Ph.D., from the University of California, Irvine, and an investigator in the Leqselvi clinical development program, said in a statement. "An oral JAK that delivers proven results will be impactful for the alopecia areata community."

Approval of Leqselvi was granted to Sun Pharma.

More Information

Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

Source: HealthDay

Posted : 2024-08-03 07:15

Read more

Disclaimer

Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.

The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Popular Keywords