Sun Pharma launches hair loss drug Leqselvi in US after patent settlement

Sun Pharmaceutical has launched a new medicine for severe alopecia areata, called Leqselvi, in the United States.

 

Alopecia areata is a condition in which the immune system attacks hair follicles, leading to hair loss on the scalp as well as other parts of the body. 

“Leqselvi is an important step forward for people living with severe alopecia areata,” said Richard Ascroft, CEO of Sun Pharma North America.

 

8 mg Leqselvi tablets for severe alopecia areata is now available by prescription across the US.

 

The delay in Sun Pharma's launch of Leqselvi in the US was caused by a patent infringement case, which was later settled in a US court with Incyte Corp, as reported by Reuters.

 

The drug underwent two clinical trials, THRIVE-AA1 and THRIVE-AA2, involving 1,223 adults between 18 and 65 years of age. The trials were conducted in the US, Canada, and Europe.

 

Hair regrowth was measured over a period of 24 weeks using a scoring system known as the Severity of Alopecia Tool (SALT), according to the company's statement.

 

Shrikant Akolkar, analyst at Nuvama Institutional Equities, said the drug could generate up to $400 million in sales by FY30, with peak sales potential of $900 million, and boost growth in Sun's key US market, according to Reuters.

 

The National Alopecia Areata Foundation (NAAF) welcomed the launch. Its President, Nicole Friedland, said the new treatment offers hope to many people dealing with the emotional and social impacts of hair loss.

 

Sun Pharmaceutical is also offering a 'Leqselvi Support Program' to help patients access the medicine. Eligible patients may be able to receive the drug for as little as $0 for up to two years. The program also includes personal guidance and support throughout the treatment process.

 

“The clinical evidence for Leqselvi is truly compelling, demonstrating consistent efficacy," said Arash Mostaghimi, Vice Chair of Clinical Trials and Innovation and Associate Professor of Dermatology at Brigham and Women's Hospital.

 

However, Leqselvi does carry certain risks. It may cause side effects such as infections, acne, headaches, or more serious health issues. Doctors are advised to screen patients thoroughly before and during treatment.

 

Alopecia areata affects nearly 2.5 per cent of people in the United States during their lifetime. According to figures cited in the company’s release, the condition also affects a similar percentage of the global population. The scalp is the most commonly affected area, but hair loss can also occur on other parts of the body.