 "sun pharma")
Drugmaker Sun Pharmaceutical Industries Ltd announced on Friday that the United States Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for deuruxolitinib for the treatment of adults with moderate to severe alopecia areata, an autoimmune disorder that can lead to hair loss. Deuruxolitinib is an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2. Janus kinase is a group of intracellular, non-receptor, non-essential amino acid-based enzymes.
The company stated that it has submitted an 8mg twice-daily regimen of deuruxolitinib for FDA review. The NDA for deuruxolitinib is based on two Phase-III trials, which included over 1,200 patients across more than 135 clinical trial sites.
Abhay Gandhi, chief executive officer of North America Business at Sun Pharma, said, "At Sun, we are committed to making a difference in the lives of patients. 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."
In its press release, Sun Pharma revealed that data from these trials were most recently presented at the 2023 American Academy of Dermatology (AAD) Annual Meeting in March and were previously presented at the 31st European Academy of Dermatology and Venereology Congress. The presentations highlighted the consistent and high-level efficacy of the 8mg dose of deuruxolitinib in both Phase-III trials. Treatment with deuruxolitinib was generally well-tolerated, and patient satisfaction was significantly higher for the 8mg dose compared with the placebo.
Nicole Friedland, president and chief executive officer of the National Alopecia Areata Foundation (NAAF), said, "We are excited that the FDA is evaluating another potential treatment option for this serious medical condition. 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 a significant unmet medical need in the community."
In May, the FDA had asked Sun Pharma to halt tests on one dosage of deuruxolitinib due to the potential for blood clot formation.
The FDA also stated that patients with alopecia areata taking the 12mg dose of deuruxolitinib should discontinue its use. Sun Pharma confirmed that there were no blood clot formations in patients taking the 8mg dose, and the FDA has not placed those trials on hold.
