Deuruxolitinib Approved by FDA to Treat Severe Alopecia
- By BSTQ Staff
Sun Pharma’s LEQSELVI (deuruxolitinib), an oral Janus kinase (JAK) inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) to treat severe alopecia areata in adults. Deuruxolitinib selectively inhibits JAK1 and JAK2, proteins involved in the immune signaling pathways believed to contribute to hair loss in alopecia areata.
LEQSELVI’s approval is based on the results of two Phase III clinical trials, THRIVE-AA1 and THRIVE-AA2, which together included 1,220 patients with at least 50 percent scalp hair loss as measured by the Severity of Alopecia Tool (SALT). In the trials, patients started with an average of only 13 percent scalp hair coverage. By week 24, one-third of the patients treated with deuruxolitinib achieved at least 80 percent scalp hair coverage, with some achieving up to 90 percent coverage. The studies demonstrated a consistent upward trend in hair regrowth among patients, with no observed plateau in efficacy at the 24-week mark. The most common adverse events reported included headache, acne and nasopharyngitis. More serious side effects, though rare, may include serious infections, malignancies, thrombosis, gastrointestinal perforations and certain laboratory abnormalities. Due to these risks, deuruxolitinib is contraindicated in patients who are CYP2C9 poor metabolizers or those taking moderate or strong CYP2C9 inhibitors.
“Two different doses that were studied showed some of the most robust efficacy we’ve seen and some of the fastest responses that we’ve seen out of any JAK inhibitor,” said James Song, MD, director of clinical research at Frontier Dermatology Partners in Seattle, Wash. Dr. Song added that safety issues did arise with a higher dose of deuruxolitinib such as higher rates of blood clots. However, he said, FDA didn’t make the patients drop down to the lower dose, so more long-term data is needed to understand the safety profile of this newer JAK inhibitor.
