FDA Approves Sun Pharma’s Leqselvi for Severe Alopecia Areata

The U.S. Food and Drug Administration (FDA0 has recently approved Leqselvi (deuruxolitinib) pills to treat adults with severe alopecia areata. It is an autoimmune disorder that causes nonscarring hair loss. 

Leqselvi is an oral selective inhibitor of Janus kinases JAK1 and JAK2. It also showed some side effects such as acne, headache and nasopharyngitis in previous clinical trials. 

This approval of Leqselvi pills was based on a study that used data from the THRIVE-AA1 and THRIVE-AA2 phase 3 clinical trials. In this study, researchers involved 1,220 patients with alopecia areata. These participants were aged between 18 and 65 years and had at least 50% scalp hair loss for over six months. They were randomly assigned to take either Leqselvi pills (12 mg) twice daily or placebo pills. Researchers used the Severity of Alopecia Tool (SALT) to measure scalp hair regrowth after 24 weeks. They mainly wanted to check whether Leqselvi pills are effective for severe alopecia areata. The primary endpoint was the percentage of patients achieving a SALT score of 20 or less at 24 weeks. 

When researchers observed the results of SALT, they found that over 30% of these people achieved substantial hair regrowth, up to 80%. On the other hand, 25% of them regained mostly complete scalp coverage after 24 weeks of treatment. The researchers also found that people who took Leqselvi showed a consistent upward trend with no plateau through 24 weeks. But researchers also noticed that some of these participants experienced common adverse events such as headache, acne and nasopharyngitis.  
 
Sun Pharma company has recently been granted approval for Leqselvi pills. But they warn that it can increase the risk of serious infections, thrombosis, malignancies, gastrointestinal perforations, and laboratory abnormalities. Hence this treatment is not recommended for patients with poor CYP2CP metabolizers or moderate or strong CYP2C9 inhibitors. 

One of the researchers, Natasha Mesinkovska said that early intervention and effective treatment for severe alopecia areata is very important. She also said that this treatment has shown positive results in trials. Hence it will be beneficial for people with alopecia areata.  

The FDA has approved Leqselvi (deuruxolitinib) pills to treat alopecia areata. It has shown its effectiveness in clinical trials. Hence healthcare professionals should consider it and suggest these pills. But they should also be aware of the side effects that it can cause.  

Reference Link:  

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