Tag Archives: sotagliflozin

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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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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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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CLEAR Outcomes Full Results; Abbott Libre 2 and 3 AID Clearance; New Lexicon HF Awareness Campaign; Merck to Advance Oral PCSK9i to Ph3; Amarin Announces Non-Sarissa Board Departures; BI/Lilly COORDINATE-Diabetes Results

A series of cardiometabolic-related news items have been observed from Esperion, Abbott, Lexicon, Merck, and BI/Lilly. Below, FENIX provides highlights and insights into the respective news items.

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Why A Lexicon Deal for Sota Feels Like Momentum Is Building

Following the EMPEROR-Preserved and FIGARO-DKD data readouts at ESC 2021, it seems as if a deal for Lexicon’s sotagliflozin should be building momentum. Below, FENIX provides thoughts on the quickly evolving HF/CKD market and insight into what a potential deal for sotagliflozin may look like, despite some caveats.

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Lexicon, Merck, and Intercept Q2 ’21 Earnings Update

Three cardiometabolic-related news items have been observed: Lexicon, Merck, and Intercept hosted their Q2 ’21 earnings calls and provided updates to their respective CV/Met businesses. Below, FENIX provides highlights and insights for the calls.

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ADA 2021 Key Press Releases (June 29)

On the final day of ADA 2021, six cardiometabolic-related press releases were observed from Novo/Walmart, Lilly, Lexicon, Hanmi, Dario, and Adocia. Below, FENIX provides context and analysis for the announcements, including an RAI price-ranking following the Novo/Walmart partnership for ReliOn NovoLog.

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Lexicon Confident in Sota HF Label After Entresto Approval; Lexicon Q4 and FY ’20 Earnings Update

Lexicon (press release) hosted its Q4 and FY ’20 earnings calls and provided updates to its diabetes business, including the company’s anticipated H2 ’21 sotagliflozin NDA filing for a heart failure indication. Recall, SOLOIST and SCORED positive results were first presented at AHA 2020 and published in the NEJM (SOLOIST-WHF publication and SCORED publication). Below, FENIX provides highlights and insights from the event.

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Thoughts on Sotagliflozin HF Indication after Entresto’s PARAGON Approval

Last week, Novartis received FDA approval for expanding the Entresto label in HF beyond HFrEF (previous FENIX insight). Ahead of Lexicon’s Q4 2020 earnings later in March, FENIX provides a reminder on the recent sequence of events in HF and thoughts on how the new HF labeling for Entresto could apply to Lexicon’s SGLTi, sotagliflozin.

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