Category Archives: SGLT2i

Novo Files Lawsuit Over Third-Party Semaglutide Promotion; Versanis Bio Completes Enrollment of Ph2b Bimagrumab Study in Obesity; FDA Approves Jardiance and Synjardy for Pediatric T2DM and Lodoco for ASCVD

Four cardiometabolic-related news items have been observed: Novo Nordisk announced it is taking legal actions over third-party semaglutide promotion (view press release); Versanis Bio announced it completed enrollment for the global Ph2b BELIEVE study evaluating the safety and efficacy of bimagrumab as a monotherapy and in combination with semaglutide in participants with obesity (view CT.gov record); FDA approved Jardiance and Synjardy to improve glycemic control in children 10 years of age and older with T2DM (view press release) as well as Agepha Pharma’s Lodoco in adult patients with established ASCVD or with multiple risk factors for cardiovascular disease (view press release). Below, FENIX provides highlights and insights into the respective news items, including brief thoughts on the bimagrumab + semaglutide program. 

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June CHMP Agenda; AstraZeneca Discontinues Oral GLP-1RA Development; Lilly Launches Insulin Affordability Awareness Campaign

Three cardiometabolic-related news have been observed: the CHMP agenda (view here) for this month’s meeting (June 19-22) has been released, including Jardiance’s EMPA-KIDNEY and Mounjaro obesity indication extensions; AstraZeneca announced it is discontinuing development of its oral, AZD0186 (view article); and Lilly announced a partnership with ADA and Adam Duvall to increase awareness of Lilly’s insulin affordability programs (view press release). Below, FENIX provides context and insight on the respective news items, including insight into how Novo’s OASIS 1 readout likely influenced AZ’s decision.

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Wegovy Advertising Paused Due to High Demand; Inventiva Ph2 Lanifibranor T2DM and NAFLD Results; FDA Accepts Gan & Lee’s Bs-Aspart BLA

Three cardiometabolic-related news items have been observed: Ro has reportedly paused its Wegovy advertising due to the ongoing supply shortage (view article); Inventiva announced positive topline results from its Ph2 trial evaluating lanifibranor in patients with T2DM and NAFLD (view press release); and Gan & Lee announced FDA accepted the BLA for its biosimilar insulin aspart (view press release). Below, FENIX provides highlights and insights into the respective news items, including thoughts on the ongoing Wegovy supply issues.

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Inpefa Label and Pre-launch Analysis

Following the Inpefa (sotagliflozin) approval on May 26, 2023 (view label; previous FENIX insight), FENIX has conducted an analysis of the Inpefa label and HCP website. Additionally, Lexicon hosted a post-approval investor call on May 30, 2023, where the company provided insight into its go-to-market strategy (view webcast). Of note, Lexicon plans to launch Inpefa in the US by the end of June 2023. Below, FENIX provides insights and thoughts on the Inpefa label and pre-launch activities.

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Sotagliflozin approved in US as “INPEFA”

Lexicon announced the FDA approval of sotagliflozin as “INPEFA” to reduce the risk of CV death, hospitalization for HF, and urgent HF visit in adults with HF (across the full LVEF spectrum) or T2DM, CKD, and other cardiovascular risk factors. The May 26 approval is consistent with FENIX’s projection following Lexicon’s July 2022 announcement that FDA accepted the re-submission and assigned a full 10-month review period (previous FENIX insight). The Inpefa label has not yet been observed at the time of this publication. Of note, Lexicon is hosting a call with investors on Tuesday, May 30 at 8am ET. FENIX will conduct a full label analysis of sotagliflozin in the coming days once the label is available.

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US Supreme Court Rules in Favor of Regeneron/Sanofi Praluent Litigation

Regeneron and Sanofi announced that the US Supreme Court upheld a previous decision by the Delaware District Court and the US Court of Appeals which held that Amgen’s asserted US PCSK9 patent claims were invalid (previous FENIX insight). Of note, the unanimous Supreme Court decision ends a nearly decade-long dispute between Sanofi/Regeneron and Amgen. Below, FENIX provides brief thoughts on the ruling.

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Farxiga DELIVER Label Analysis

Earlier this week, FDA approved Farxiga (dapagliflozin) to reduce the risk of CV death, hospitalization for HF, and urgent HF visit in adults with HF, regardless of baseline LVEF (view updated Farxiga label; previous FENIX insight). The label extension was based on positive results from the Ph3 DELIVER trial (view CT.gov record). Recall, in February 2023, Forxiga received EU approval for the expanded HF indication (previous FENIX insight). Below, FENIX has conducted a Farxiga HF label analysis in the context of the Jardiance HF indication.

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Structure Therapeutics Advances Oral GLP-1RA to Ph2; Embecta and Tidepool Partner for T2DM Patch Pump AID Development; New SOLOIST-WHF Analysis

Three cardiometabolic-related news items have been observed: Structure Therapeutics announced it is advancing its oral GLP-1RA (GSBR-1290) into Ph2a development for T2DM and obesity (view press release); Embecta announced it has partnered with Tidepool to develop an AID system for its T2DM patch pump (view press release); and Lexicon announced results from an investigator-initiated analysis of SOLOIST-WHF which demonstrated that sotagliflozin is cost-effective at commonly accepted willingness-to-pay thresholds in patients with diabetes and worsening HF (view press release). Below, FENIX provides highlights and insights into the respective news items.

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AZ’s Farxiga Receives FDA Approval for DELIVER; Esperion, Xeris, Madrigal, and Sigilon Q1 ’23 Earnings; Ascensia Expands Eversense PASS Program; and Glooko Redesigns App

A series of cardiometabolic-related news items have been observed from AstraZeneca, Ascensia, and Glooko. Additionally, Esperion, Xeris, Madrigal, and Sigilon provided Q1 ’23 earnings updates. Below, FENIX provides highlights and insights into the respective news items.

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Ionis, Lexicon, and Amarin Q1 ’23 Earnings; AstraZeneca Collaborates with Sernova for Cell Therapies

Four cardiometabolic-related news items have been observed: Ionis (view press release; slides), Lexicon (view press release), and Amarin view press release; slides) hosted their respective Q1 ‘23 earnings calls and provided CVRM-related updates; and Sernova announced a preclinical research collaboration with AstraZeneca to evaluate the use of its Cell Pouch System with AstraZenaca’s therapeutic cells (view press release). Below, FENIX provides highlights and insights into the respective news items. 

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