Sun Pharmaceutical Industries has presented new data highlighting the clinical efficacy and safety of LEQSELVI (deuruxolitinib) 8 mg tablets at the 44th Annual Fall Clinical Dermatology Conference, held in Las Vegas, Nevada.

LEQSELVI 8 mg tablets was approved by the US Food and Drug Administration for the treatment of adults with severe alopecia areata (AA) earlier this year. LEQSELVI, a JAK inhibitor, treats alopecia areata at the source and is clinically proven to deliver statistically significant efficacy.

LEQSELVI data presented at Fall Clinical includes pooled long-term results from open-label extension (OLE) studies showing ongoing and clinically meaningful improvements in scalp hair regrowth in adults with AA taking LEQSELVI for up to 68 weeks.

To determine long-term efficacy, the Severity of Alopecia Tool (SALT) scores were analyzed using two methods: Last Observation Carried Forward (LOCF) and As Observed (AO).

At the end of the qualifying trial period at Week 24, 32.6 percent of patients receiving LEQSELVI 8 mg BID (twice daily) achieved a SALT ≤20 score; the percentage of SALT 20 responders increased to 48.8 percent (LOCF analysis) and 76.6 percent (AO analysis) at Week 68 of the OLE studies. Additionally, 99.6 percent (282 patients) maintained their response to LEQSELVI 8 mg BID (as defined by sustaining a SALT ≤50 after achieving SALT ≤20 during the OLE studies as of the cutoff date).

“This research provides insight into the durability of response experienced with LEQSELVI 8 mg twice daily, adding to a growing body of evidence highlighting the benefits of this treatment for those living with severe alopecia areata. These data highlight an important role for deuruxolitinib in the care of patients living with this disease,” said Brett King, MD, PhD.

In addition to the OLE study, two posters presented at Fall Clinical capture patient and clinician feedback for the treatment of AA which confirm the preference for treatment options with fast time to onset and proven efficacy, irrespective of dosing schedules. In the blinded treatment scenario displaying profiles of LEQSELVI, baricitinib and ritlecitinib, patients and clinicians chose the profile of LEQSELVI as the preferred therapeutic option.

“As we continue to grow the Sun Pharma dermatology portfolio, the data presented at Fall Clinical support a growing body of clinical evidence which show LEQSELVI is an effective treatment option for those living with severe alopecia areata,” said Marek Honczarenko, MD, PhD, Senior Vice President and Head of Global Development at Sun Pharma.

“We’re excited to share these important data with the dermatology community and look forward to seeing patients living with alopecia areata access this innovative treatment option.”

LEQSELVI may cause serious side effects including serious infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. There also may be an increased risk of mortality and major cardiovascular events.

LEQSELVI should not be used in patients who are CYP2C9-poor metabolizers or who are taking moderate or strong CYP2C9 inhibitors. In placebo-controlled trials, the three most common adverse events were headache (12.4 percent as compared to 9.4 percent with placebo), acne (10 percent as compared to 4.3 percent with placebo), and nasopharyngitis (8.1 percent as compared to 6.7 percent with placebo).