Sun Pharma North America has officially launched LEQSELVI, a new treatment option for severe alopecia areata, aimed at providing relief to eligible patients and their healthcare providers. Richard Ascroft, CEO of Sun Pharma North America, emphasized that introducing this innovative therapy addresses the significant unmet needs of patients affected by this condition.
With the limited treatment choices available for those living with severe alopecia areata in the United States, the arrival of LEQSELVI is considered a vital development. Clinical trials of LEQSELVI revealed rapid and promising results, showing that approximately one-third of patients regained nearly all of their hair by the 24-week mark. Remarkably, 3% of participants achieved 80% or greater scalp coverage as soon as eight weeks into the treatment.
Arash Mostaghimi, MD, MPA, MPH, FAAD, who serves as Vice Chair of Clinical Trials and Innovation and is an Associate Professor of Dermatology at Brigham and Women’s Hospital, spoke highly of the clinical evidence supporting LEQSELVI. He noted that the treatment provides clinicians with a powerful new tool capable of delivering significant and rapid outcomes for patients suffering from alopecia areata.
The psychosocial effects of severe alopecia areata can be profound, with many individuals experiencing psychological distress and loss of self-confidence due to the unpredictable nature of hair loss. This highlights the urgent need for effective therapeutic solutions. A recent survey indicated that 83% of patients prefer treatments characterized by speed, demonstrating the critical nature of quick regrowth.
Nicole Friedland, President and CEO of the National Alopecia Areata Foundation (NAAF), expressed optimism about the introduction of LEQSELVI, stating it offers hope to the community. NAAF expressed its enthusiasm for expanding treatment options and the opportunity for individuals to access an FDA-approved solution for hair loss linked to this autoimmune disease.
However, it is essential to note that LEQSELVI comes with potential serious side effects, including risks of severe infections, malignancies, and thrombosis, among others. Furthermore, there is a noted increase in the risk of mortality and major cardiovascular events associated with the treatment. The medication is contraindicated for patients who are CYP2C9 poor metabolizers or those taking moderate to strong CYP2C9 inhibitors. In clinical trials, common side effects included headache, acne, and nasopharyngitis, with incidences noted as greater than in placebo groups.
To ensure access to LEQSELVI, Sun Pharma has established the LEQSELVI SUPPORT™ Program. This initiative allows eligible patients to receive their medication at little to no cost for up to two years while providing personalized support throughout the treatment process. Detailed information about LEQSELVI can be found on their official website.
LEQSELVI, known scientifically as deuruxolitinib, is an oral selective inhibitor of Janus kinases JAK1 and JAK2. It has been approved for use in adults suffering from severe alopecia areata. Alopecia areata is an autoimmune condition wherein the immune system mistakenly attacks hair follicles, causing partial or complete hair loss on both the scalp and body, potentially affecting around 2.5% of the U.S. and global population during their lifetime.
The THRIVE-AA1 and THRIVE-AA2 trials, which are randomized and double-blind, assessed the effectiveness of deuruxolitinib in 1,223 adult patients aged 18-65 with severe alopecia areata across various sites in the U.S., Canada, and Europe. The studies focused on hair regrowth after a 24-week treatment period, utilizing the Severity of Alopecia Tool (SALT) score for measurement. Participants were randomly assigned to receive either 8 mg or 12 mg doses of LEQSELVI or a placebo for the duration of the trials.
The primary measure of success for these clinical trials was the percentage of patients achieving a SALT score of 20 or less at the 24-week evaluation. Initial enrollment requirements mandated that participants exhibit at least 50% scalp hair loss, as evaluated by the SALT scoring system, where a score of 100 indicates total scalp hair loss, while 0 indicates no hair loss. The average baseline SALT scores for patients in both trials were approximately 85.9 and 87.9, respectively.
For prescribing LEQSELVI, healthcare providers must conduct specific evaluations prior to treatment. These evaluations include CYP2C9 genotype testing and assessments for the use of moderate or strong CYP2C9 inhibitors, active and latent tuberculosis testing, viral hepatitis screening, and a complete blood count. It’s advised that LEQSELVI not be administered to patients with significant renal or hepatic impairment.
In conclusion, the launch of LEQSELVI is a notable development in the quest for effective treatments for severe alopecia areata. Both patients and healthcare providers now have access to a treatment that not only shows promise based on clinical evidence but also offers the potential for rapid, significant improvement in hair regrowth, thus alleviating some of the psychological impact associated with this condition.
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