Tag Archives: Mounjaro

Wegovy SELECT Label Analysis; CMS Opens Obesity Coverage

FDA recently approved the Wegovy label expansion to reduce the risk of MACE in adults with either overweight or obesity and established CVD (view updated Wegovy label; previous FENIX insight). The label expansion is based on the SELECT CVOT which demonstrated a -20% RRR in 3P-MACE for non-T2DM people with established CVD who were treated with QW 2.4mg injectable semaglutide (previous FENIX insight). Following the approval, Medicare has issued guidance to Part D plans stating anti-obesity drugs also treating medically accepted indications should be reimbursed (view article). Below, FENIX has conducted a Wegovy label analysis, including insight into the impact of the recent CMS decision.

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Awiqli (QW Insulin Icodec) Receives Positive CHMP Opinion; Oprah TV Special Spotlights Zepbound and Wegovy

Two cardiometabolic-related news items have been observed: CHMP adopted a positive opinion, recommending marketing authorization for “Awiqli” (QW insulin icodec) for the treatment of diabetes in adults (view press release); and Oprah hosted a show on ABC titled, “Shame, Blame, and the Weight Loss Revolution” which addressed the stigma associated with obesity and the success of GLP-1RAs (view article; watch episode on HULU). Below, FENIX provides highlights and insights for the respective news items, including brief thoughts on the social media hype following Oprah’s TV special.

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Mounjaro and Zepbound Launch Updates; Tirzepatide Ph2 MASH Data; Lilly’s Smart Insulin Enters Ph1; Lilly Q4 ’23 Earnings Update

Lilly hosted its Q4 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. Of note, the company announced topline tirzepatide Ph2 SYNERGY-NASH data, discussed Zepbound launch updates, provided insight into manufacturing capacity increases, and disclosed its glucose-responsive insulin has entered clinical development, among other pipeline updates. Below, FENIX provides highlights and insights from the call.

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New Insulin Patch Pump; Pfizer Q4 ‘23 Earnings; Lilly Initiates Ph2 LA Amylin Obesity Trial; Lilly Trying to Get Mounjaro Reimbursed in Germany

A series of cardiometabolic-related news items have been observed from Modular Medical, Pfizer, and Lilly. Below, FENIX provides highlights and insights for the respective news items, including thoughts on why the new patch pump from Modular Medical may be an acquisition/partnership target by Medtronic.

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Lilly to Launch Mounjaro in EU; FDA Posts Libre 3 Android App Recall; Novo Initiates Ph1 Cagrisema Study in Weight Loss Mechanisms

Three cardiometabolic-related news items have been observed: Lilly has reportedly planned additional Mounjaro launches in 2024 once it receives EU approval for its pen injector (view article); FDA posted a Class 2 device recall for the Libre 3 Android App which was resolved in February 2023 (view recall); and Novo initiated a Ph1 cagrisema study (view CT.gov record). Below, FENIX provides highlights and insights for the respective news items.

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JPM 2024 Day 2: ABT, PODD, NVO, LLY, AZN, BAY, BMF, TDOC; Embecta Files 510(k) for T2DM Patch Pump; Omada Partners with Amazon for Cardiometabolic Programs

On the second day of JPM 2024, FENIX has provided coverage of presentations by major CVRM companies, including Abbott, Insulet, Novo Nordisk, Lilly, AZ, Bayer, Biomea, and Teladoc. GSK and Sanofi also presented at JPM 2024 but had no meaningful discussion relating to their respective CVRM portfolios. Separately, two CVRM-related news items have been observed: Embecta announced it submitted a 510(k) filing to FDA for its open-loop patch pump for T2DM (view press release); and Omada Health announced a partnership with Amazon’s Health Condition Programs for its cardiometabolic programs (view press release).

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Roche Restructures Diabetes Business; Novo Partners for Obesity and MASH; BI Partners with Ribo for MASH; Lilly Issues Open Letter on Off-Label Mounjaro/Zepbound Use; Lilly Launches Diabetes/Obesity Digital Health Program; Evaluate Projects Novo and Lilly to Top 2024 Global New Sales

A series of cardiometabolic-related news items have been observed from Roche, Novo, Lilly, BI, and Evaluate. Below, FENIX provides highlights and insights for the respective news items.

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Novo Expands Production Facilities in France; Novo to Reduce Production of Victoza for Ozempic Supply; Mounjaro vs. Ozempic in Real-World Study; Kaleido Launches AID System; Biodexa Acquires T1DM Asset; 89bio Long-term MASH Data; Dario Contracts for Cardiometabolic Solution

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Truveta, ViCentra, Biodexa, 89bio, and Dario. Below, FENIX provides highlights and insights for the respective news items.

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