Sun Pharmaceutical Industries Ltd on Friday announced that the United States Food and Drug Administration (USFDA) has accepted its new drug application (NDA) for Deuruxolitinib, an investigational drug for the treatment of moderate to severe alopecia areata.

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Sun Pharmaceuticals in the NDA has submitted 8mg twice daily regimen of the new drug for the review by the US drug regulator.

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.

According to Abhay Gandhi, CEO - North America Business, Sun Pharma, Deuruxolitinib has the potential to be an important new treatment option for people suffering with alopecia areata. Olumiant (Baricitinib, launched) of Eli Lilly, Pfizer’s Ritlecitinib (under approval process) and Concert’s Deuruxolitinib are the three products that are in advanced stages for the treatment of alopecia areata.

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As per the filing, alopecia areata may affect up to 2.5 percent of the US and global population during their lifetime.

The NDA filing for Deuruxolitinib is based on two Phase III trials which included more than 1,200 patients across more than 135 clinical trial sites.

According to the filing, the trials highlighted consistent and high-level efficacy with Deuruxolitinib at the 8 mg dose.

Sun Pharma acquired the patent for Deuruxolitinib drug by acquiring US-based Concert Pharmaceuticals for $576 million earlier this year.

However, a US Appeals Court has upheld an order that ruled in the favour of a plea by Incyte Corp challenging the grant of the patent.

Analysts at HSBC had earlier stated that the ruling raised the risk of payment to Incyte and a delay in the launch of the drug for Sun Pharma.

Sun Pharma shares were trading 0.92 percent higher at Rs 1130.20 apiece on BSE at 10.59 AM.

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(Edited by : Asmita Pant)

First Published:Oct 6, 2023 11:46 AM IST