On the fourth day of EASD 2025, four key news items were observed from Roche, Novo Nordisk, and Lilly. Below, FENIX provides context and analysis for the announcements.
Three cardiometabolic-related news items have been observed: Lilly initiates the Ph3 MOVE-Lp(a) CVOT of muvalaplin in patients with elevated Lp(a) and ASCVD (view CT.gov record); Vivani Medical announced updated development plans for its semaglutide implant (view press release); and WHO updates essential medicines list to include Novo’s and Lilly’s GLP-1RAs (view article; view list). Below, FENIX provides highlights and insight for the respective news items.
Lilly announced FDA approval of high-dose Trulicity (3.0 and 4.5mg; view updated label here) which is in-line with FENIX’s projection of August-September 2020 (previous FENIX insight). Per the updated Trulicity label, patients requiring additional glycemic control can uptitrate to the 3.0mg Trulicity dose after 4 weeks on the 1.5mg dose. An additional 4 weeks on the 3.0mg dose is required before moving to the 4.5mg dose. Below, FENIX provides an overview of the high-dose Trulicity label update and additional thoughts its approval.
Lilly announced results from the AWARD-11 high-dose Trulicity trial have been published in the Journal of the Endocrine Society, although only the abstract was available at the time of this blast. Interestingly, while both the 3.0 and 4.5 mg dulaglutide doses met statistical significance according to the efficacy estimand analysis, only the 4.5mg dose reached statistical significance for the treatment-regimen estimand analysis. The 3.0mg miss on A1C is in-line with FENIX’s previous hypothesis following Lilly’s AWARD-11 topline announcement in June 2019. Below FENIX provides a brief summary of the AWARD-11 data as found in the Lilly press release.
Lilly hosted its Q1 ’20 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that the empa T1DM program has been discontinued. Separately, AstraZeneca announced plans to evaluate Farxiga as a treatment for hospitalized COVID-19 patients who are at increased risk of complications, such as organ failure. The trial is being conducted at Saint Luke’s Mid America Heart Institute and led by Mikhail Kosiborod. Below, FENIX provides highlights and insights from the Lilly earnings call as well as thoughts on the new AZ trial.
The CHMP agenda for this week’s meeting (September 16-20) has been released, and it includes two notable items (REWIND and dapa/saxa/met triple FDC opinions). Below, FENIX provides diabetes-related highlights and insights from the CHMP agenda.
Yesterday, ADA announced updates to its Living Standards of Medical Care in Diabetes. The Living Standards of Care revision now incorporates REWIND CV data, Victoza use in pediatric patients, and the international consensus report on CGM time-in-range goals. Below, FENIX provides thoughts and market implications for each of the respective guideline updates.