Sun Pharmaceutical Industries announced that Leqselvi (deuruxolitinib) is featured in seven presentations at the 2026 European Academy of Dermatology and Venereology (EADV) Congress, including an oral presentation of long-term safety data from a European Open-Label Extension (OLE) study in adults with severe Alopecia Areata (AA).
The oral presentation reported safety findings from up to two years of open-label treatment. The safety profile of Leqselvi remained generally consistent with previous clinical experience. Most treatment-emergent adverse events were mild or moderate, while treatment discontinuations due to adverse events were uncommon. No deaths, thrombosis or major adverse cardiovascular events were reported among patients receiving the FDA-approved 8 mg twice-daily dose.
Long-term efficacy data from the European OLE also showed sustained scalp hair regrowth through Week 108. Among patients who were treatment responders at OLE baseline, maintained their response at Week 52 and continued treatment, 93.9 percent maintained their response at Week 108. Among baseline nonresponders, 76.6 percent achieved a response by Week 52. Of those who continued in the study after responding at Week 52, 96.8 percent maintained their response through Week 108.
The Severity of Alopecia Tool (SALT) score was used to assess scalp hair loss, with a score of 100 representing complete scalp hair loss and 0 indicating no scalp hair loss.
Additional pooled post hoc analyses of the THRIVE-AA1 and THRIVE-AA2 studies showed consistent efficacy across clinically relevant patient subgroups, including patients with baseline eyebrow, eyelash or nail involvement and those with shorter- or longer-duration disease episodes.
Leqselvi is a JAK inhibitor used for the treatment of severe alopecia areata. The medicine can reduce the body's ability to fight infections and is not indicated for CYP2C9 poor metabolisers or patients taking a CYP2C9 inhibitor. Tuberculosis testing and blood work are recommended before and during treatment.
The prescribing information includes warnings regarding serious infections, blood clots, cancers including lymphoma, and gastrointestinal perforations. Patients aged 50 years and older with cardiovascular risk factors may have an increased risk of heart attack, stroke or death when taking a JAK inhibitor. Healthcare professionals should also be informed about infections, hepatitis B or C, pregnancy or plans for pregnancy, and problems involving low blood sugar.
Sun Pharma said the EADV 2026 data provide additional information on the long-term safety, durability of response and maintenance of clinical benefit associated with Leqselvi in adults with severe alopecia areata.
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