Drugs

Lilly Reports ‘Positive’ Retatrutide Data in Trial Versus Ozempic

Eli Lilly is reporting “positive topline results” from TRANSCEND-T2D-2, a head-to-head Phase 3 trial comparing retatrutide with Novo Nordisk’s injectable Ozempic 2 mg in adults with Type 2 diabetes. “At 80 weeks, retatrutide met the primary and all key secondary endpoints, delivering greater A1C reduction and substantially more weight loss than Ozempic,” Lilly says. An NDA is being planned for early next year.

"In TRANSCEND-T2D-2, the first Phase 3 trial comparing retatrutide with another incretin medicine, retatrutide delivered greater A1C reduction and more than double the weight loss of the highest approved dose of Ozempic for type 2 diabetes,” a company release says. Based on these results and those from across our Phase 3 program, we believe retatrutide, if approved, could shift the treatment paradigm for people living with type 2 diabetes, obesity and related cardiometabolic conditions."

The trial data showed that both doses of retatrutide lowered A1C by an average of 2.2% compared to 1.8% with Ozempic at 80 weeks. Those taking retatrutide lost an average of 44.3 lbs (19.5%; 9 mg) and 47.4 lbs (20.9%; 12 mg) compared to 20.9 lbs (9.4%) with Ozempic. “Retatrutide also delivered greater improvements than Ozempic across certain cardiovascular risk factors, including non-HDL cholesterol, triglycerides and systolic blood pressure,” Lilly says.

Steps Proposed to Modernize U.S. Clinical Studies

A Duke Margolis Institute for Health Policy white paper, “From Research to Care: Modernizing U.S. Clinical Studies for Cures Into Care,” lists several priority actions that it says private organizations and collaborations need to take to reform the U.S. fragmented clinical research system. The report reviews the current

HHS Allows Compounding of 6 Peptides Despite FDA Staff Objections

HHS has announced an interim enforcement-discretion policy allowing state-licensed pharmacies, federal facilities and licensed physicians to compound six previously restricted peptides under specified conditions while FDA considers whether to formally authorize their use under Section 503A of the Federal Food, Drug, and Cosmetic Act. The 10/28 policy

Law Firm Provides Overview of Guide on Drug Use-Related Software

FDA’s recent final guidance Regulatory Considerations for Prescription Drug Use-Related Software provides sponsors with a “more concrete framework for navigating the boundary between FDA-required and promotional labeling, while placing a premium on early regulatory planning,” according to a new Akin legal analysis. The guidance outlines how prescription

FDA, EMA Working Together on Herbal/Botanical Drugs

A 9/25 joint FDA/European Medicines Agency (EMA) workshop on “Regulatory Perspectives on Herbal Medicinal/Botanical Drug Development” set the stage for future joint activities in the herbal/botanical space, despite regulatory differences in the ways in which the two jurisdictions approach the products. An interview in an FDA

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Steps Proposed to Modernize U.S. Clinical Studies

HHS Allows Compounding of 6 Peptides Despite FDA Staff Objections

Law Firm Provides Overview of Guide on Drug Use-Related Software

FDA, EMA Working Together on Herbal/Botanical Drugs