Tag Archives: Lilly

Thoughts on High-dose Trulicity Data

Late last week, Lilly announced that results from the AWARD-11 high-dose Trulicity trial had been published, with data showing up to -1.9% reduction in A1C and -10.4lb weight loss at 36 weeks with the 4.5mg dulaglutide dose (previous FENIX insight). Below, FENIX has conducted an AWARD-11 comparative analysis and provides thoughts on high-dose Trulicity in the context of Novo’s Ozempic and Lilly’s tirzepatide.

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High-dose Trulicity Data (AWARD-11) Published in the Journal of the Endocrine Society

Lilly announced results from the AWARD-11 high-dose Trulicity trial have been published in the Journal of the Endocrine Society, although only the abstract was available at the time of this blast. Interestingly, while both the 3.0 and 4.5 mg dulaglutide doses met statistical significance according to the efficacy estimand analysis, only the 4.5mg dose reached statistical significance for the treatment-regimen estimand analysis. The 3.0mg miss on A1C is in-line with FENIX’s previous hypothesis following Lilly’s AWARD-11 topline announcement in June 2019. Below FENIX provides a brief summary of the AWARD-11 data as found in the Lilly press release.

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Abbott Q1 ’20 Earnings Update; Provention Bio Initiates Rolling BLA for Teplizumab; Lilly Launches Additional Humalog AGs; Insulet’s COVID-19 Response

A series of diabetes-related news has been observed: Abbott hosted its Q1 ’20 earnings update, Provention Bio announced the initiation of a rolling BLA submission for teplizumab, Lilly announced the launch of lispro authorized generics (LAG) for Humalog Mix 75/25 and Humalog Junior, and Insulet initiated its COVID-19 response plan. Below, FENIX provides highlights and insights for the respective news items.

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Trulicity CV Protection DTC Initiated; Lilly Announces $35 Co-Pay for COVID-19 Help

Two diabetes-related items have recently been observed from Lilly: the launch of the Trulicity CV protection patient DTC and a press release announcing Lilly’s Insulin Value Program and $35 co-pay as a COVID-19 response measure. Below, FENIX provides thoughts on the CV protection indication promotion for Trulicity, how it compares to Novo Nordisk’s recent Ozempic CV protection indication DTC, and brief thoughts on the Lilly insulin program.

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FENIX Analysis: Ozempic and Trulicity CV Indication Initial Promotion

Novo Nordisk and Lilly have updated their Ozempic and Trulicity HCP websites with new messaging for their respective CV protection indications. Below, FENIX provides an initial HCP website promotional analysis, which includes insight into how the differences in the respective indications could potentially blur HCP perceptions of the Ozempic and Trulicity brands.

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Lilly to Join New Part D Senior Savings Model for Affordable Insulins; Welldoc Partners With Dexcom

Yesterday, FENIX observed a series of diabetes-related news including an announcement that Welldoc partnered with Dexcom to integrate G6 into the BlueStar platform (press release) as well as Lilly plans to participate in the new Part D Senior Savings Model for affordable insulins (press release). Below, FENIX provides brief thoughts on these announcements.

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Tirzepatide CVOT Record Available on CT.gov

A new CT.gov record for Lilly’s tirzepatide CVOT (SURPASS CVOT) has been observed. The trial details are consistent with Lilly’s discussion during its recent Q4 ’19 earnings call. Below, FENIX provides an overview and brief thoughts on the SURPASS CVOT study.

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Rybelsus and URLi Receive Positive CHMP Opinions

Two important positive CHMP opinions were received this week for Novo Nordisk’s Rybelsus and Lilly’s ultra-rapid lispro product (to be branded as Liumjev). Below, FENIX provides thoughts on the positive CHMP opinions including insight into the ongoing US FDA review of Lilly’s URLi.

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Lilly to Donate Insulin Pens; Fractyl Launches Revita DMR in the UK

Two diabetes-related news items have been observed including an announcement from Lilly that the company is donating 200k insulin pens over 3 years and Fractyl is launching its Revita DMR device in the UK. Below, FENIX provides highlights and insights from the respective news items.

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Trijardy XR (empa/lina/met XR FDC) Approved; Trijardy Label and Market Analysis

Late yesterday, Boehringer Ingelheim and Lilly announced FDA approval for their empagliflozin+linagliptin+metformin XR triple FDC, branded as “Trijardy XR.” Below, FENIX has conducted a Trijardy XR label analysis which includes a comparison to AstraZeneca’s Qternmet XR (dapa+saxa+met XR) as well as thoughts on the potential impact of the triple FDCs on the OAD market segment.

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