Tag Archives: Diabetes

Xultophy Label Update at Parity with Soliqua

According to Drugs@FDA, Xultophy label was updated to expand the indication for use in patients uncontrolled on OADs. Additionally, the new label also included 3 other major changes: 1) recommended starting dose, 2) clinical data from DUAL I, DUAL IV trials and 3) a caution for audible clicks. Of note, Novo did not issue a press release on this FDA approval. Below, FENIX provides an analysis of the updated Xultophy label and its impact on the injectable market segment.

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Janssen Diabetes VP Moves to Vertex

As of February 2019, Janssen’s VP and Franchise Medical Leader for the metabolism business, Gary Meininger (pictured below), has left Janssen and is now the SVP and Head of Pipeline Development for Vertex Pharmaceuticals. Prior to his ~9 years at Janssen, Meininger spent 8 years at Merck as a director of Merck Research Laboratories. Below, FENIX provides brief thoughts on Meininger’s departure.

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Soliqua Label Update More Competitive vs. Xultophy and Basaglar

Sanofi announced FDA approval of an updated Soliqua label to expand its indication to patients uncontrolled on OADs. Additionally, Soliqua stability has been extended from 14 days to 28 days (vs. 21 days for Novo’s Xultophy). Below, FENIX provides thoughts on how Sanofi will likely leverage the updated Soliqua indiction to position Soliqua as the first injectable as well as increasing Sanofi’s competitive position vs. Xultophy and Basaglar.

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Tandem and Mylan Q4 ’18 Earnings Updates

Tandem Diabetes Care and Mylan both hosted their respective Q4 ’18 earnings calls. Of note, Mylan did not discuss its biosimilar insulin programs (including bs-glargine) or bs-glucagon. Below, FENIX provides highlights and insights from the Tandem earnings call.

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Diabetes Takes a Backseat During Part II Drug Pricing Hearing

Today, the Senate Finance Committee held the second drug pricing hearing of 2019 (Drug Pricing in America: A Prescription for Change, Part II). Part I was held on January 29, 2019. While the Part I drug pricing hearing spent much time discussing insulin pricing, diabetes-specifically was hardly mentioned. When a specific drug was mentioned, it was most often AbbVie’s Humira. Below, FENIX provides diabetes-related highlights and insights from the hearing.

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MannKind Q4 ’18 Earnings Update

MannKind hosted its Q4 ’18 earnings call and provided updates to its Afrezza business including commercial and clinical activities. Below are highlights and insights from the call.

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Omnipod Horizon Receives Breakthrough Device Designation; Q4 ’18 Earnings Update

Insulet hosted its Q4 ’18 earnings call and provided updates to its Omnipod business including the development of the Omnipod Horizon hybrid closed-loop. Of note, this is believed to be the first time that Insulet disclosed it received Breakthrough Device Designation for Omnipod Horizon. Below are highlights and insights from the call.

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Farxiga eGFR Cutoff Lowered; Positive Brilinta T2DM Data

AstraZeneca’s Farxiga franchise labels (Farxiga and Xigduo) have been updated to reduce the eGFR cutoff from 60 to 45 mL/min/1.73m2. Additionally, AZ announced positive topline results from the Brilinta Ph3 THEMIS study in patients with established CAD and T2DM. Below, FENIX provides insight into the lower Farxiga eGFR as well as thoughts on AZ’s strengthening CV protection market position.

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Thoughts on New Hygieia d-Nav Mobile App for Insulin Titration; New Data published in The Lancet

Hygieia recently announced it received 510(k) clearance for a mobile app that is part of the company’s d-Nav insulin guidance service. Recall, d-Nav is a T2DM-focused, cloud platform that provides personalized insulin dose recommendations based on the user’s BGM values. Additionally, results were published in The Lancet for a study showing d-Nav plus HCP support led to superior glycemic control than with HCP support alone. Below, FENIX provides thoughts on how Hygieia’s d-Nav and other similar systems could impact the diabetes market.

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Dexcom Expands Customer Support; Q4 ’18 Earnings Update

Dexcom hosted its Q4 ’18 earnings call and provided updates to its diabetes business including an announcement that the company is expanding its customer and technical support capabilities through ex-US resources. As such, Dexcom is downsizing an undisclosed portion of its US workforce. Below, FENIX provides highlights and insights from the earnings call.

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