Lilly's Mounjaro Demonstrates Superior Efficacy in Head-to-Head Trials Against Diabetes Competitors
• Eli Lilly's Mounjaro (tirzepatide) has shown superior efficacy in reducing HbA1c levels and body weight compared to Novo Nordisk's Ozempic in clinical trials, offering new hope for the 35 million Americans with type 2 diabetes.
• As the first dual-action medication that stimulates both GLP-1 and GIP receptors, Mounjaro achieved mean HbA1c reductions of 1.7% to 2.4% across trials, with participants losing between 12-25 pounds depending on dosage.
• Recently launched in India following CDSCO approval, Mounjaro is now indicated for both chronic weight management in adults with obesity or overweight with comorbidities, and as an adjunct treatment for type 2 diabetes mellitus.
FDA Accepts Gilead's Lenacapavir for HIV Prevention with Priority Review
• The FDA has accepted Gilead's NDA for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, as pre-exposure prophylaxis (PrEP).
• Lenacapavir demonstrated 100% risk reduction in cisgender women and 96% risk reduction in a diverse population, compared to background HIV incidence.
• The FDA has granted priority review with a target action date of June 19, 2025, potentially making it the first twice-yearly HIV prevention option.
• Gilead is also pursuing global access, including submissions to the EMA and voluntary licensing agreements to facilitate availability in low- and middle-income countries.
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