Zydus aims to launch first new drug in US by early 2026

India’s Zydus Lifesciences is aiming to launch its first new drug in the United States by early 2026, looking to tap into the multi-billion dollar market for treating a type of liver disease, Managing Director Sharvil Patel told Reuters.

The company received a fast-track designation from the U.S. FDA for its Saroglitazar drug, used to treat Primary Biliary Cholangitis (PBC), a chronic inflammatory liver disease, in 2020 . The treatment also has orphan drug tags from the FDA and European regulators.

Zydus will enter a competitive field, with an FDA decision on CymaBay’s PBC drug due in August. Gilead Sciences announced its acquisition of CymaBay for $4.3 billion earlier in February.

Saroglitazar, currently in a mid-to-late-stage trial for PBC, is also being tested for Metabolic Dysfunction-Associated Steatohepatitis (MASH), a type of fatty liver disease.”

The Ahmedabad, India-based company is looking to acquire rare disease platforms similar to its unit’s acquisition last year of a drug to treat Menkes disease, which affects the metabolism of copper in the body.

“That is one business area where we are looking to acquire and build more of these rare disease platforms,” Patel said. Zydus also plans on launching a generic version of Novo Nordisk’s popular diabetes and weight-loss drug – Semaglutide – after its patent expires in India and has already started developing the injectable, Patel said. Zydus joins other Indian peers Sun Pharma Cipla , Dr Reddy’s, and Lupin, who are also working on their versions of the drug, popularly sold as Ozempic for diabetes and Wegovy for weight loss.

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