Sun Pharma receives US FDA approval for dermatological drug; details inside

Deuruxolitinib is an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2, for the treatment of adults with moderate to severe alopecia areata.

At 3 pm, the shares of Sun Pharmaceutical Industries were trading at Rs 1127.90, up by 0.71% from its previous closing of Rs 1119.90 on the BSE.

Sun Pharma has announced that the U.S. Food and Drug Administration (FDA) has officially accepted their New Drug Application (NDA) for deuruxolitinib, an investigational oral inhibitor targeting Janus kinases JAK1 and JAK2. This application is intended for the treatment of adults who are dealing with moderate to severe alopecia areata. Sun Pharma’s NDA submission specifically includes a regimen of 8 mg twice daily for deuruxolitinib, which is now under FDA review.

The NDA submission for deuruxolitinib to the U.S. FDA is grounded in the results of two pivotal Phase III trials known as THRIVE-AA1 and THRIVE-AA2. These trials collectively involved more than 1,200 patients across a vast network of over 135 clinical trial sites. The data from these trials was most recently presented at the 2023 American Academy of Dermatology (AAD) Annual Meeting in March and had previously been showcased at the 31st European Academy of Dermatology and Venereology Congress.

During these presentations, particular emphasis was placed on the consistently high efficacy demonstrated by deuruxolitinib at the 8 mg dosage in both Phase 3 trials. Notably, significant differences in achieving the clinically meaningful SALT score of ≤20 for the treatment group, when compared to the placebo, were observed as early as Week 8 of the studies. Moreover, this high level of effectiveness was maintained throughout the duration of the trials. Importantly, treatment with deuruxolitinib was generally well-tolerated, and patients reported significantly higher levels of satisfaction when compared to those in the placebo group.

Sun Pharmaceutical Industries is the world’s fourth-largest speciality generic pharmaceutical company and India’s top pharmaceutical company. The company is engaged in the business of manufacturing, developing and marketing a wide range of branded and generic formulations and Active Pharma Ingredients (APIs). The company and its subsidiaries have various manufacturing facilities spread across the world with trading and other incidental and related activities extending to the global market.

Earlier this week, the company entered into an agreement to acquire around 37.76% equity shareholding of Ezerx Health Tech (EzeRx). The cost of acquisition will be Rs 28.69 crore. EzeRx is engaged in the production, marketing and distribution of non-invasive diagnostic and ancillary medical devices in and outside India.

On Friday, the stock opened at Rs 1126.05 and touched a high and low of Rs 1130.80 and Rs 1123.30 respectively. The BSE group ‘A’ stock of face value of Rs 1 has a 52-week high and low of Rs 1,169.90 and Rs 922.55, respectively.

Last one week high and low of the scrip stood at Rs 1160.95 and Rs 1112, respectively. The current market cap of the company is Rs 2,70,542.67 crore. The promoters holding in the company stood at 54.48%, while Institutions and Non-Institutions held 36.23% and 9.29%, respectively.