Sun Pharma's Breakthrough Treatment Gets USFDA Nod

Sun Pharmaceutical Industries Ltd. received a significant boost as the United States Food and Drug Administration (USFDA) accepted its New Drug Application (NDA) for Deuruxolitinib, a promising drug targeting moderate to severe alopecia areata.

Alopecia areata, an autoimmune disorder leading to hair loss, currently has limited treatment options available. Sun Pharma submitted an 8mg twice daily dosage of Deuruxolitinib for USFDA review. This oral medication selectively inhibits Janus kinases JAK1 and JAK2, presenting a potential breakthrough for treating adult patients with alopecia areata.

Abhay Gandhi, CEO of North America Business at Sun Pharma, highlighted Deuruxolitinib's potential as a crucial treatment option for those struggling with this condition. Alongside Sun Pharma's Deuruxolitinib, Eli Lilly's Olumiant (Baricitinib) and Pfizer's Ritlecitinib (awaiting approval) are also promising treatments for alopecia areata.

The NDA filing is based on two Phase III trials encompassing over 1,200 patients across 135 clinical trial sites. These trials consistently demonstrated the high efficacy of Deuruxolitinib at the 8mg dose.

While Sun Pharma acquired the patent for Deuruxolitinib through its purchase of US-based Concert Pharmaceuticals for $576 million earlier this year, a US Appeals Court's ruling in favor of Incyte Corp's patent challenge could potentially impact Sun Pharma's launch plans for the drug.