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  • Zydus Lifesciences...

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

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-02-28T16:30:55+05:30  |  Updated On 21 March 2024 5:48 PM IST
USFDA grants Fast Track Designation to Zydus Usnoflast for amyotrophic lateral sclerosis
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Ahmedabad: 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.
Read also: Cipla, Dr Reddys and other Indian Pharma companies now in race to develop Wegovy versions
Original news source: https://www.reuters.com/business/healthcare-pharmaceuticals/zydus-aims-launch-first-new-drug-us-by-early-2026-2024-02-27/
zydus lifescienceszydus lifesciences newssaroglitazarprimary biliary cholangitis
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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