Sun Pharma Gets USFDA Nod for Alopecia Treatment Drug

India's largest drugmaker Sun Pharmaceuticals on Friday, July 26 informed the exchanges that it has received the United States Food and Drug Administration (USFDA) approval for a New Drug Application (NDA) called Deuruxolitinib, used in the treatment of Alopecia Areata.

Key Takeaways from Sun Pharma’s Nod for Alopecia Treatment Drug from USFDA

• Sun Pharmaceuticals on Friday received the United States Food and Drug Administration (USFDA) approval for a New Drug Application (NDA) called Deuruxolitinib, used in the treatment of Alopecia Areata.
• Alopecia Areata is a common autoimmune condition in which hair loss is assumed to occur as a result of immunological privilege breakdown.
• The drug, known as LEQSELVI, will be available in the form of 8 mg tablets and used to treat people with severe alopecia areata.
• The drug is expected to generate $200 million in sales over the following three to four years, expanding Sun Pharma's speciality portfolio.

Alopecia Areata is a common autoimmune condition in which hair loss is assumed to occur as a result of immunological privilege breakdown, which causes the immune system to attack the hair follicles, resulting in abrupt hair loss on the scalp, face, and occasionally other regions of the body.

The drug, known as LEQSELVI, will be available in the form of 8 mg tablets and used to treat people with severe alopecia areata.

According to Sun Pharma, the LEQSELVI approval is based on results from two multicenter double-blind placebo-controlled phase 3 studies with about 1,220 patients enrolled. The US Drug Administration had authorised the file acceptance of the Deuruxolitinib NDA.

“LEQSELVI offers a new and effective solution that will significantly enhance options for long-suffering patients battling severe alopecia areata and their physicians,” said Abhay Gandhi, CEO, North America Business, Sun Pharma. “Our fast-growing dermatology business is excited to add this novel treatment to its portfolio,” Gandhi added.

At baseline, the typical patient had just 13% scalp hair covering. Sun Pharma said that by the 24th week, one-third of those patients had achieved 80% scalp hair coverage.

Furthermore, the drug is expected to generate $200 million in sales over the following three to four years, expanding Sun Pharma's speciality portfolio.

About Sun Pharmaceuticals Industries Limited

Sun Pharmaceuticals Industries Limited is a global leader in specialty generics, offering consumer healthcare goods as well. It is India's largest pharmaceutical firm and a top generics provider in the US and emerging countries. Sun Pharma's worldwide speciality portfolio includes revolutionary treatments in dermatology, ophthalmology, and onco-dermatology, accounting for nearly 18% of total revenues. The company's vertically integrated activities provide high-quality medications that are trusted by physicians and consumers in over 100 countries. Its production plants span six continents. Sun Pharma is proud of its diverse staff from over 50 nationalities.

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About LEQSELVI

LEQSELVI (deuruxolitinib) 8 mg tablets is an oral selective inhibitor of Janus kinases JAK1 and JAK2 that has been licensed to treat adult patients with severe alopecia areata. Alopecia areata is an autoimmune condition in which the immune system assaults the hair follicles, causing partial or full hair loss on the scalp and body. Alopecia areata can affect up to 2.5% of the US and global population during their lifespan.3,6,7 The scalp is the most usually afflicted location, however, any hair-bearing site can be impacted independently or in conjunction with the scalp. The condition can develop at any time throughout one's life and affects both men and women. Alopecia areata can lead to major psychological repercussions, such as anxiety and sadness. There are currently limited authorised treatment options available for alopecia areata.