Indiana
Friday’s approval comes after a previous rejection in October 2023 due to manufacturing concerns.
The late-stage clinical trial results showed that Eli Lilly’s once-weekly insulin efsitora matched daily injections for patients with type 1 and 2 diabetes, respectively.
Eli Lilly’s weekly insulin injection efsitora alfa secured two late-stage victories on Thursday in a potential blow to rival Novo Nordisk, which in July failed to secure the FDA’s approval for its basal insulin icodec.
Through its online pharmacy LillyDirect, Eli Lilly announced Tuesday it will allow patients to purchase single-dose vials of Zepbound—without the autoinjector—at a 50% discount or more versus other incretin obesity treatments.
MBX Biosciences follows Bicara Therapeutics and Zenas Biopharma, which also announced last week their respective plans to go public in a potential boost to the recent slump in the IPO market.
Experts say Novo Nordisk and Eli Lilly’s GLP-1 drugs are unlikely to reach more countries in the near term, but Sanofi’s diabetes treatment has gained ground globally.
Eli Lilly released topline Phase III data on Tuesday showing that after more than three years of follow-up, pre-diabetic patients treated with tirzepatide were less likely to progress to type 2 diabetes.
Eli Lilly comfortably cleared analyst estimates in the second quarter after improving supply of its blockbuster tirzepatide brands Mounjaro and Zepbound, which together generated more than $4 billion in sales.
All doses of Eli Lilly’s type 2 diabetes medication Mounjaro and weight-loss drug Zepbound are now available, according to an update on Friday to the FDA’s drug shortage database.
Eli Lilly on Thursday released late-stage data showing a 38% reduction in the risk of heart failure outcomes, as it plays catch-up with Novo Nordisk’s semaglutide which won the FDA’s cardio nod in March.
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