Category Archives: GLP-1RA

Lilly Doubles Down on LillyDirect Program; Tandem AID Algorithm Cleared for T2DM; Compounders Sue FDA… Again; Lilly Acquires FXR Program; Terns Development Updates

A series of cardiometabolic-related news items have been observed from Lilly, Tandem Diabetes Care, the Outsourcing Facilities Association, Lilly/Organovo, and Terns Pharmaceuticals. Below, FENIX provides highlights and insights for the respective news items. 

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Lilly Stockpiles Orfoglipron; February CHMP Agenda Observed

Two cardiometabolic-related news items have been observed: Lilly has stockpiled $548M worth of orforglipron in a risky move ahead of the regulatory filing/approval (view 10-K); and the CHMP agenda (view here) for this month’s meeting (Feb 24-27) has been released. Below, FEINX provides highlights and insights for the respective news items.  

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Lilly and OliX Partner in MASH; Hims & Hers Super Bowl Ad Controversy; Novartis Initiates Pelacarsen/Inclisiran Trial in Lp(a)

Three cardiometabolic-related news items have been observed: OliX Pharmaceuticals announced a partnership with Lilly in MASH (view press release); Hims & Hers received congressional scrutiny over the company’s Super Bowl ad (view article); and Novartis initiated a Ph3 pelacarsen/inclisiran Lp(a) trial (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items.  

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Ozempic CKD Label and Website Analysis

FDA recently approved the Ozempic label expansion to reduce the risk of kidney disease worsening, kidney failure (end-stage kidney disease), and death due to CVD in adults with T2DM and CKD (view label). The approval is based on the Ph3b FLOW trial (view CT.gov record) which demonstrated a -24% reduction in the primary composite endpoint (previous FENIX insight). Below, FENIX has conducted an analysis of the updated Ozempic label and patient/HCP websites.

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