With this designation, LG Chem will receive benefits such as exclusive sales rights in the US market for seven years, subsidies and tax cuts for clinical testing costs in the US, and preliminary consulting support related to development
Participants taking tirzepatide lost up to 52 lb. (24 kg) in this 72-week phase 3 study
Company to launch product after the expiry of semaglutide patent in India
Galenicum will oversee development, manufacturing and supply, while Lupin will handle regulatory submissions, approvals, and commercialization and distribution of Semaglutide across 23 countries globally
The FDA also noted that current prescribing information for GLP-1 RAs already includes warnings about the risk of suicidal thoughts
The new assets expand Biocon Biologics’ already robust oncology portfolio, which now includes 17 cancer therapies
The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety
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Fasting glucose improved by 12.3 mg/dL, while liver stiffness dropped 23.7%, signaling a direct hepatic benefit
The approval introduces a needle-free alternative to injectable GLP-1 therapies
The approval is supported by data from three pivotal clinical trials
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