Tag Archives: Wegovy

SELECT up for CHMP Opinion?; April CHMP Agenda; BI Partners for MASH; Lilly Acquires Nexus Manufacturing Site

Three cardiometabolic-related news items have been observed: The CHMP agenda for this month’s meeting (April 22-25) has been released and SELECT is likely up for an opinion (view CHMP agenda); Ochre announced it entered into a partnership with BI for liver disease (view press release); and Lilly announced an agreement to acquire an injectables manufacturing facility from Nexus Pharmaceuticals (view press release). Below, FENIX provides highlights and insights into the respective news items.

This content is for Read Less members only.
Already a member? Log in here

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.

This content is for Read Less members only.
Already a member? Log in here

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.

This content is for Read Less members only.
Already a member? Log in here

CBO Hints at Medicare Coverage for Obesity Drugs; AZ Initiates Ph3 Balcinrenone/Dapa Trial

Two cardiometabolic-related news items have been observed: The CBO has hinted at potential Medicare coverage for obesity drugs, such as Wegovy and Zepbound (view article); and AZ initiated a Ph3 balcinrenone+dapa trial in HF and impaired kidney function (view CT.gov record). Below, FENIX provides highlights and insights from the respective news items.

This content is for Read Less members only.
Already a member? Log in here

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.

This content is for Read Less members only.
Already a member? Log in here

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. 

This content is for Read Less members only.
Already a member? Log in here

New Novo Once-Monthly Dual-Agonist; Icodec Delayed; Novo Q4 ’23 Earnings Updates

Novo Nordisk hosted its Q4 ’23 earnings call (press release; slides) and provided updates across its CVRM portfolio. The company made a number of important disclosures during the call, including a new QM GLP-1+GIP dual agonist in development, QW insulin icodec has been delayed in the US, STEP HFpEF has been filed in the US and EU, and more. Additionally, Novo reminded its 2024 CMD is being held on March 7, 2024. Of note, FENIX will also cover Novo’s London Q4 ’23 earnings call tomorrow, February 1, 2024. Below, FENIX provides highlights and insights from the call.

This content is for Read Less members only.
Already a member? Log in here

SELECT up for CHMP Opinion?; January CHMP Agenda; Akero Initiates Ph3 EFX MASH Trial

Two cardiometabolic-related news items have been observed: the CHMP agenda (view here) for this month’s meeting (January 22-25) has been released and includes Novo’s SELECT; and Akero initiated the second Ph3 study evaluating EFX in participants with non-cirrhotic MASH and F2 or F3 fibrosis (SYNCHRONY Histology; view CT.gov record). Below, FENIX provides highlights and insights for the respective news items.

This content is for Read Less members only.
Already a member? Log in here