Category Archives: Topics

Dexcom Analyst Day Overview

Dexcom hosted its first ever Analyst Day and provided updates across its business including the company’s strategy to expand its market opportunity to non-intensive T2DM, gestational diabetes, and CGM use in hospitals. Of note, Dexcom displayed a picture of the fully disposable second generation Verily CGM which is being positioned as the product that will allow Dexcom to enter the non-intensively managed T2DM market. Below, FENIX provides an overview of the Analyst Day as well as thoughts on Dexcom’s pipeline activities and commercial opportunity. Pipeline Roadmap Dexcom senior management provided an overview of its pipeline activities including device integrations, predictive……

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New Mylan and Lilly trials: Ph3 biosimilar insulin aspart study, Ph2 URLi study in 670G

Last week, new Mylan and Lilly trials were observed on CT.gov. These include a Ph3 biosimilar insulin aspart study in T1DM by Mylan and a Ph2 URLi study by Lilly with Medtronic’s 670G closed-loop system. Below, FENIX provides thoughts on each of the respective studies. Mylan Ph3 Biosimilar Insulin Aspart Study in T1DM Mylan has initiated a Ph3 study for its biosimilar insulin aspart in T1DM with NovoLog as the comparator. This new trial is in-line with previous guidance from Mylan indicating the initiation of a Ph3 study in H2 ’18. Previously, it was anticipated that Mylan would initiate a 52-week Ph3 trial……

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Small Lantus Label Update

According to Drugs@FDA, the Lantus SoloStar label has been updated with changes in “Section 2.1 Dosage and Administration.” Below, FENIX provides additional details on the updated dosing instructions in comparison to the other marketed basal insulins. The updated label language (see excerpt below) includes the 1-unit dose dialing increments for the Lantus SoloStar pen. In addition to this change, a warning note has been added regarding audible clicks for visually impaired patients. Source: Lantus Solostar label from Drugs@FDA database The updated dosing instructions for unit dosage dialing and use in visually impaired patients seems to be consistent with other marketed……

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Nothing New in Sota Adcom Federal Register Announcement

Today, the FDA published a notice in the Federal Register announcing the sotagliflozin adcom for Jan 17, which was press released yesterday by Lexicon. No notable new details were provided, and the proposed indication is in-line with expectations as “…Adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.”

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Sotagliflozin Adcom in T1DM Scheduled for January 17, 2019

Today, Lexicon announced that FDA will hold an advisory committee meeting for Zynquista (sotagliflozin in T1DM) on January 17, 2019. This news is in-line with previous guidance from Lexicon’s Q3 ‘18 earnings call. Recall, the PDUFA date for Zynquista is March 22, 2019 (previous FENIX insight). FENIX will provide coverage and analysis of the FDA briefing documents as well as the adcom meeting. The following updates are occurring in the map: Adcom announcement is being added under respective map entries… If you receive our email blasts, you already have an account. Log in nowContext counts when making decisions.Purchase Blast$599.00You can read the article’s full…

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New Novo Ph2 study for QW Insulin 287 in T2DM

Last week, Novo initiated a Ph2 trial for the company’s QW basal insulin analog, “Insulin 287” (NN1436), in T2DM patients. This new trial is in line with previous guidance from Novo’s Q1 ’18 earnings call, indicating the Ph2 initiation of Insulin 287 by YE 2018 (see presentation slide below). FENIX provides thoughts on this new Ph2 T2DM trial for Insulin 287 including the use of CGM, observations about dose titration, and the potential for a Ph2 T1DM trial. Source: Novo Q1 ’18 earnings presentation Although Novo previously indicated the completion of Ph1 Insulin 287 trials, additional Ph1 studies have been observed (previous FENIX insight)…….

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Thoughts on New ACC T2DM ASCVD Recommendations

The ACC published their 2018 ACC Expert Consensus Decision Pathway on Novel Therapies for CV Risk Reduction in Patients with T2DM and ASCVD in JACC. Notably, the ACC recommends SGLT2i use for potential CV benefits and GLP-1RA use for those patients who may have an unsuitable risk profile for SGLT2i use. Below, FENIX provides a winners-and-losers analysis based on the recent ACC recommendations compared to the updated ADA/EASD guidelines from October 2018.

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Invokana CANVAS promotion observed on patient and HCP websites

J&J recently updated the Invokana patient and HCP websites to reflect the recent approval of the Invokana CV indication, i.e., reduction of 3P-MACE from CANVAS/R (previous FENIX insight). Of note, this is the first OAD drug to receive an indication for 3P-MACE risk reduction. Below, FENIX provides additional details on messaging across the SGLT2i class. The updated Invokana patient website indicates that “Invokana is the only type 2 diabetes pill approved to help lower your A1C and reduce the risk of major cardiovascular events including heart attack, stroke, CV death.” The updated promotion depicting a male character doing a heart sign also seems to be new…….

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Tresiba U-100 10mL vial FDA approved

According to Drugs@FDA, Novo Nordisk has received US approval for the commercialization of a 10mL vial of Tresiba U-100. Of note, Novo has not received approval for a U-200 vial. Below FENIX provides additional details on the new vial, specifically as it pertains to pediatric use.

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Thoughts on PIONEER-6 Results

On Friday, Novo Nordisk announced positive top-line results from the oral semaglutide CVOT, PIONEER-6. Although PIONEER-6 did not meet superiority for 3P-MACE, Novo reported statistically significant (ss) ~50% RRRs for CV death and all-cause mortality. Below, FENIX discusses the likelihood for the semaglutide franchise to receive a CV risk reduction indication in the context of the somewhat divergent PIONEER-6 results, a description of different filing scenarios against Lilly characterized as high likelihood, low likelihood, and “power move”, what an FDA adcom could look like, and finally, external factors of influence. PIONEER-6 consistency check Below is a table comparing the results……

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