Tag Archives: Novo Nordisk

FDA Adcom Votes 4-7 Against Insulin Icodec T1DM Approval

Today, FDA held an Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to discuss the use of Novo Nordisk’s QW insulin icodec in T1DM patients, and panelists voted 4-7 against the icodec benefit/risk profile in T1DM patients. The split vote is largely unsurprising in the context of FDA’s concerns raised in the adcom briefing documents (previous FENIX insight). Below, FENIX provides highlights and insights from the icodec adcom, including additional thoughts on how a T2DM-only icodec indication would be a significant win for Novo (and Lilly).

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

Full FLOW Results at ERA; Lilly Increases Manufacturing Investment to $9B

Two cardiometabolic-related news items have been observed: the full FLOW results were presented at ERA 2024 and simultaneously published in the NEJM (press release); and Lilly announced it increased its manufacturing investment for tirzepatide API production (press release). 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 to Face Uphill Battle; Insulin Icodec Adcom Briefing Documents Available

Briefing documents have been posted for FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) meeting to discuss the use of Novo Nordisk’s QW insulin icodec in T1DM patients (view here) which is being held on May 24, 2024. Below, FENIX provides an overview of FDA’s thoughts/concerns about the icodec benefit/risk profile and a prediction on how the adcom will turn out.

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

Novo London, Tandem, and Lexicon Q1 ’24 Earnings

Three cardiometabolic-related news items have been observed: Novo hosted its post-Q1 ’24 earnings London analyst event (view webcast); and Tandem (press release) and Lexicon (press release) hosted their respective Q1 ’24 earnings calls. 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

FTC Investigating Diabetes and Obesity Orange Book Patent Listings; Pfizer and Amarin Q1 ’24 Earnings Update

Three cardiometabolic-related news items have been observed: FTC has expanded its investigation targeting “junk patent listings” for Novo’s diabetes and weight loss drugs, among others (view press release); Pfizer hosted its Q1 ’24 earnings (press release; slides; infographic); and Amarin hosted its Q1 ’24 earnings call (view press release). 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

Lilly Initiates Retatrutide CV and Renal Outcomes Study; Novo Initiates New Ph3 Cagrisema Maintenance Dose Study; US Senate Investigates Ozempic/Wegovy Pricing; Teladoc Q1 ’24 Earnings; Vance Swanson Joins Beta Bionics

A series of cardiometabolic-related news items have been observed from Lilly, Novo Nordisk, US Senate HELP Committee, Teladoc, and Beta Bionics. 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

Icodec FDA Adcom Scheduled for May 2024

FDA has requested an adcom meeting on May 24, 2024, to discuss Novo Nordisk’s QW insulin icodec (view unpublished FDA document here). Recall, Novo previously disclosed FDA extended the icodec regulatory review by three months, with a decision now anticipated in Q3 2024 (previous FENIX insight). Below, FENIX provides insight on the potential implications and reasoning for an icodec adcom, including readthrough to Lilly’s QW insulin, efistora alfa.

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

Lilly Loses Counterfeit Tirzepatide Lawsuit; EMA Finds No Link Between GLP-1RAs and Suicide Ideation; Diamyd Ph3 Recruitment Update

Three cardiometabolic-related news items have been observed: Lilly loses counterfeit tirzepatide lawsuit (view article); EMA found no link between GLP-1RAs and suicide ideation (view meeting highlights); and Diamyd reached a recruitment milestone for its Ph3 DIAGNODE-3 trial in T1DM (view press release). 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