USFDA Accepts Sun Pharma's NDA For Deuruxolitinib
Sun Pharmaceutical Industries on Friday in a statement said that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for deuruxolitinib, an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2, for the treatment of adults with moderate to severe alopecia areata. In the NDA, Sun Pharma has submitted 8mg twice daily regimen of deuruxolitinib for FDA review, the company said in an exchange filing.
“We believe that deuruxolitinib has the potential to be an important new treatment option for people who continue to struggle every day with the chronic nature of alopecia areata," said Abhay Gandhi, CEO, North America Business, Sun Pharma.
Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. Alopecia areata may affect up to 2.5 per cent of the United States and global population during their lifetime. The onset of the disease can occur throughout life and affects both women and men. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression with currently limited treatment options available .
The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials (THRIVE-AA1 and THRIVE-AA2), which included over 1200 patients across more than 135 clinical trial sites. Data from these trials were most recently presented at the 2023 American Academy of Dermatology (AAD) Annual Meeting in March and previously presented at the 31st European Academy of Dermatology and Venereology Congress, the company said in a statement. The presentations highlighted the consistent and high-level efficacy of deuruxolitinib at the 8 mg dose in both Phase 3 trials. Significant differences in achieving the clinically meaningful SALT score ≤20 for the treatment arm compared to placebo were seen as early as Week 8 and were maintained throughout the studies. Treatment with deuruxolitinib was generally well-tolerated and patient satisfaction was significantly higher for the 8mg dose compared with placebo, the company's statement read.
The THRIVE-AA1 and THRIVE-AA2 trials included 1,223 adult participants aged 18-65 with moderate to severe alopecia areata from locations in the U.S., Canada, and Europe. These trials aimed to assess scalp hair regrowth after 24 weeks of treatment using the SALT score. Participants were randomly assigned to receive either 8 mg or 12 mg of deuruxolitinib twice daily or a placebo for 24 weeks. The primary measure of success was the percentage of patients achieving a SALT score of 20 or lower at the end of the 24-week period. To qualify for these trials, patients needed to have at least 50 per cent scalp hair loss due to alopecia areata, as indicated by their SALT score. Notably, a SALT score of 100 signified complete scalp hair loss, while a score of 0 represented no scalp hair loss. On average, patients in THRIVE-AA1 had a baseline SALT score of approximately 85.9, while those in THRIVE-AA2 had a baseline score of around 87.9.
“People living with alopecia areata are dealing with more than just hair loss. Alopecia areata is a chronic autoimmune disease with psychological and emotional effects, and there is still significant unmet medical need in the community. We are excited that the FDA is evaluating another potential treatment option for this serious medical condition,” said Nicole Friedland, President and Chief Executive Officer of the National Alopecia Areata Foundation (NAAF).
