Tag Archives: Diabetes

Novo Q4 ’19 London Earnings; Sanofi and BD Q4 ’19 Earnings Updates

Novo Nordisk hosted its post-Q4 ’19 earnings event in London. Furthermore, Sanofi and Becton Dickinson held their respective Q4 ’19 earnings calls. Below, FENIX provides highlights and insights from the earnings calls including Sanofi’s plans to divest its interest in efpeglenatide as well as thoughts on how Novo’s QW basal insulin icodec could have broader implications to the hybrid closed-loop market.

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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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Merck Keeps Januvia As it Spins Off Other Legacy Brands

In conjunction with Merck’s Q4 and FY 2019 earnings call, the company announced plans to create a spin-off company with assets from Merck’s Women’s Health, Legacy Brands, and Biosimilars business. There was no mention of Merck/Pfizer’s Steglatro franchise on the call. Below, FENIX provides highlights from the Merck earnings call as well as insights as to why Januvia is not included in the spinoff company.

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Dexcom Non-intensive G6 CGM Updated Approval; Dexcom G5 Receiver Recall; FDA Concludes MET NDMA Impurity Investigation

A series of diabetes-related news has been observed including a new 510(k) clearance for Dexcom’s G6 iCGM in non-intensive diabetes management, Dexcom G5 Mobile Class 2 Device recall, and FDA finalized its investigation into potential metformin impurities. Below, FENIX provides highlights and insights for the respective news items.

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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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Thoughts on New CVS Program to Eliminate Diabetes Drug OOP Costs

CVS Health recently announced a new program called “RxZERO,” which is said to completely eliminate all out of pocket costs (OOP) for diabetes prescription drugs. According to the press release, RxZERO will provide the benefit to members “without raising costs for the plan sponsor or increasing premiums or deductibles for all plan members.” Below, FENIX provides thoughts on the RxZERO program in the context of the ongoing drug pricing debate in the US.

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Lilly and Roche Q4 ’19 Earnings Updates

Lilly and Roche hosted their respective Q4 and FY 2019 earnings calls and provided updates to their respective diabetes businesses. Of note, Lilly disclosed additional information regarding the impending initiation of the tirzepatide T2DM CVOT, and Roche indicated it plans to pursue smartphone pump control. Below, FENIX provides highlights and insights from the calls including thoughts on how Lilly’s tirzepatide CVOT trial design compares to the 2008 FDA Guidance.

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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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