USFDA Nods Sun Pharma's NDA For Autoimmune Disease Treatment

Deuruxolitinib is an experimental medication for the treatment of moderate to severe alopecia areata, and Sun Pharmaceutical Industries Ltd. has reported that the United States Food and Drug Administration (USFDA) has approved its new drug application (NDA). Sun Pharmaceuticals included an 8mg twice day regimen of the novel medication in the NDA for the US drug authority to consider. 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.

There are limited treatment options available for alopecia areata. Sun Pharma in a filing to exchanges stated that Deuruxolitinib, an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2, is suggested for the treatment of adults with moderate to severe alopecia areata, as per cnbctv18. Deuruxolitinib, according to Abhay Gandhi, CEO of North America Business, Sun Pharma, has the potential to be a significant new therapy option for those suffering with alopecia areata. Eli Lilly's Olumiant (Baricitinib, launched), Pfizer's Ritlecitinib (under approval), and Concert's Deuruxolitinib are the three medications in advanced stages for the treatment of alopecia areata. According to the filing, alopecia areata may affect up to 2.5 percent of the US and global population at some point in their lives. The NDA for Deuruxolitinib is based on two Phase III studies that enrolled over 1,200 patients across 135 clinical trial locations.