Tag Archives: Novo Nordisk

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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SELECT Approved by FDA

Novo Nordisk announced FDA approved the Wegovy label expansion to reduce the risk of MACE including CV death, non-fatal MI, or non-fatal stroke in adults with either overweight or obesity and established CVD. The approval is based on the SELECT CVOT which demonstrated -20% RRR in 3P-MACE for non-T2DM people with established CVD who were treated with QW 2.4mg semaglutide (previous FENIX insight). FENIX will conduct a full label analysis of the SELECT label in the coming days. In case you missed it, FENIX conducted a full SELECT results analysis in November 2023 (previous FENIX insight).

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BI/Zealand Win with Positive Ph2 MASH Data; Novo Partners with Neomorph for Drug Discovery; Modular Medical Raises $10M

A series of cardiometabolic-related news items has been observed: BI and Zealand announced positive Ph2 survodutide MASH data; Neomorph announced it entered into a drug discovery partnership with Novo Nordisk for molecular glue degraders in cardiometabolic and rare diseases (view press release); and Modular Medical closed a $10M public offering (view press release). Below, FENIX provides highlights and insights into the respective news items, including thoughts on how BI/Zealand’s strategy in MASH may be different than Lilly (and Novo) due to their existing market positions in obesity. 

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Insulet Q4 ’23 Earnings; SELECT CHMP Decision in April?; Silence Achieves $10M Milestone Payment from AZ

Three cardiometabolic-related news items have been observed: Insulet hosted its Q4 ’23 earnings call (press release; slides); EMA reportedly intends to issue a decision for the potential use of Wegovy in treating heart disease by April (view article); and Silence Therapeutics announced it achieved a $10M milestone payment followed by the initiation of a Ph1 trial by AstraZeneca (view press release). Below, FENIX provides highlights and insights for the respective news items.

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Novo Settles Counterfeit Semaglutide Lawsuits; New Ph2 Oral GLP-1RA Study from Jiangsu Hengrui Pharmaceuticals; CSL Fails CSL112 Pivotal Trial; Eversense E3 CGM Medicare Coverage; Biocon CY Q4 ’23 (FY Q3 ’24) Earnings

A series of cardiometabolic-related news items have been observed from Novo Nordisk, Jiangsu Hengrui Pharmaceuticals, CSL, Ascensia, and Biocon. Below, FENIX provides highlights and insights for the respective news items.

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Novo Acquires Catalent for Manufacturing Capacity; Amgen Publishes MariTide Results; Beyond Type 1 Launches National Initiative for Diabetes

Three cardiometabolic-related news items have been observed: Novo Nordisk and Catalent announced Novo Holdings will acquire Catalent to boost manufacturing capacity; Amgen published animal and Ph1 SAD/MAD obesity data of its GLP-1RA/GIP antagonist (mariTide) in Nature Metabolism (view publication); and Beyond Type 1 announced the launch of a national outreach and education initiative, Huddle for Diabetes (view press release). Below, FENIX provides highlights and insights for the respective news items, including thoughts on Novo’s Catalent acquisition. 

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