Sun Pharma hits all time high on US FDA nod for alopecia drug 'Leqselvi'

This came after Sun Pharmaceuticals announced that the US Food and Drug Administration (USFDA) has approved its new drug application for Deuruxolitinib, a new treatment for Alopecia Areata

The Indian pharmaceutical giant Sun Pharmaceutical's stock soared up to 2.80 per cent, hitting all time high at 1711.95 per share on the BSE in Friday'’s intraday trade. 

This came after Sun Pharma announced that the US Food and Drug Administration (USFDA) has approved its new drug application for Deuruxolitinib, a new treatment for Alopecia Areata. This drug, branded as ‘Leqselvi’, will be available in 8 mg tablet form for adult patients.

The approval follows positive results from two multi-center, double-blind, placebo-controlled Phase 3 trials involving approximately 1,220 participants, the company said in an exchange filing on Friday.

The USFDA's endorsement of  ‘Leqselvi’ is based on these studies, which demonstrated significant efficacy in treating severe cases of Alopecia Areata.

Abhay Gandhi, CEO of Sun Pharma’s North America Business, highlighted the significance of  ‘Leqselvi’, stating, "This innovative treatment provides a new and effective option for patients suffering from severe alopecia areata. We are thrilled to expand our dermatology portfolio with this breakthrough medication."

In clinical trials, patients with an average of only 13 per cent scalp hair coverage at the start saw a substantial improvement, with one-third achieving 80 per cent scalp hair coverage by the 24th week.

Alopecia areata is a common autoimmune disease in which hair loss is thought to occur due to the collapse of immune privilege, leading to the immune system targeting the hair follicles and causing sudden hair loss on the scalp, face and sometimes other areas of the body. 

‘Leqselvi ‘is a new, twice daily oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2. As a JAK inhibitor, ‘Leqselvi’ interrupts the pathways thought to contribute to hair loss in severe alopecia areata, the company said.

The drug is expected to generate approximately $200 million in sales over the next three to four years and will enhance Sun Pharma’s specialty drug portfolio.

The pharma company has a total market capitalisation of Rs 4.07 trillion, according to BSE. The company’s shares are trading at a price to earnings multiple of 139.79 times with an earning per share of Rs 11.91.

At 12:14 PM; the shares of the company were trading 1.54 per cent higher at Rs 1690.90 per share on the BSE. By comparison, the BSE Sensex was up by 0.82 per cent at 80,693 levels.