Tag Archives: finerenone

Kerendia Early Launch and HCP Website Analysis

Bayer has updated its Kerendia HCP website with new messaging for finerenone following FDA approval in July 2021. Recall, the Kerendia HCP website previously was active with simple “now approved” messaging and was bare aside from a link to the press release, webinar sign up, speak with a Kerendia representative, and the prescribing information. Of note, the patient website appears to be largely unchanged since the initial approval. Below, FENIX provides an analysis of the initial Kerendia HCP messaging and early Kerendia Rx data, including a time-aligned launch comparison with other key brands.

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Finerenone Likely to Remain an Add-on to SGLT2i; FIGARO-DKD and FIDELITY Results @ ESC 2021

Findings from the Ph3 FIGARO-DKD study were presented at ESC 2021 during a Hot Line Session and simultaneously published in the NEJM. Results demonstrated a 13% RRR in the primary composite endpoint (CV death, non-fatal MI, non-fatal stroke, or hHF). Furthermore, the FIDELITY meta-analysis from FIGARO-DKD and FIDELIO-DKD was also presented. Below, FENIX provides highlights, insights, and implications, including thoughts on if/how Bayer’s interest in Lexicon’s sotagliflozin may be evolving.

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Omnipod 5 Delayed; Insulet, Provention Bio, and Bayer Q2 ’21 Earnings Updates

Insulet (press release), Provention Bio (press release), and Bayer (press release; slides) hosted their respective Q2 ’21 earnings calls. Importantly, Insulet disclosed the projected Omnipod 5 FDA clearance and launch have been delayed. Below, FENIX provides highlights and insights from the calls.

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Finerenone Label and Website Analysis

Bayer recently announced 10mg and 20mg finerenone, branded as “Kerendia,” received FDA approval. The approval of finerenone is based on the positive results of the FIDELIO-DKD study which demonstrated an 18% RRR in the primary composite endpoint. Below, FENIX has conducted a Kerendia label and website analysis.

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Finerenone Approved in US as “Kerendia”

Bayer announced the FDA approval of 10mg and 20mg finerenone, branded as “Kerendia,” to reduce the risk of sustained eGFR decline, end-stage kidney disease, CV death, non-fatal MI, and hHF in adults with CKD associated with T2DM (see logo below). The approval of finerenone is based on the positive results of the FIDELIO-DKD study and the timing comes in-line with FENIX’s projection. Recall, results from FIDELIO-DKD were presented at Kidney Week in October 2020 and demonstrated an 18% RRR in the primary composite endpoint. Finerenone is currently under review in the EU, China, and multiple other countries worldwide. FENIX will conduct a full label analysis of finerenone in the coming days once the label is available.

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Bigfoot Unity Receives 510(k) Clearance; Bayer’s FIGARO-DKD Meets Primary Endpoint; Viatris Q1 ’21 Earnings Update; Novo Insulin Product Samples Recalled

A series of cardiometabolic-related news items have been observed: Bigfoot announced FDA granted 510(k) clearance for its Bigfoot Unity Diabetes Management System which features connected smart pen caps integrated with Abbott’s Libre 2 CGM; Bayer announced the Ph3 FIGARO-DKD CVOT evaluating finerenone in ~7,400 adults with CKD and T2DM has met its primary endpoint; Viatris hosted its Q1 ’21 earnings call; and Novo Nordisk announced a voluntary recall of 1,468 Levemir, Tresiba, Fiasp, Novolog, and Xultophy product samples due to improper storage temperature conditions. Below, FENIX provides highlights and insights for the respective news items.

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Thoughts on Bayer’s 2021 Capital Markets Day

Earlier this week, Bayer hosted its 2021 Capital Markets Day and provided a company-wide update (view transforming pharma slides; view pharma R&D slides). Bayer’s President of Pharmaceuticals, Stefan Oelrich, provided a strategic update on the business, insights into the ongoing transformation, and the path for creating value through 2024. Unsurprisingly, finerenone and Verquvo (vericiguat) were highlighted as key parts of the company’s return-to-growth strategy in the context of the impending Xarelto and Eylea LOEs. Below, FENIX provides highlights and insights from the Bayer 2021 CMD event related to CVRM.

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Novo Invests in Danish Facility for Oral Sema Production; MNKD, PRVB, ICPT, BAYRY, and IONS Q4 ’20 Earnings Updates

A series of cardiometabolic-related news items have been observed: Novo Nordisk announced plans to invest 500M DKK (~82M USD) to expand its oral tablet production facilities in Måløv, Denmark; and Mannkind, Provention Bio, Intercept, Bayer, and Ionis hosted their Q4 and FY ’20 earnings call. Below, FENIX provides highlights and insights for the respective news items.

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EMPEROR-Reduced Filed with EMA; November 2020 CHMP Agenda; Bayer Submits Finerenone to FDA and EMA; Xeris Q3 ’20 Earnings Update

A series of diabetes-related news items have been observed: the November 2020 CHMP agenda has been released and includes one notable item, EMPEROR-Reduced; Bayer announced it has filed finerenone for patients with CKD and T2DM with the FDA and EMA; and Xeris hosted its Q3 ’20 earnings call. Below, FENIX provides highlights and insights from the respective news items, including thoughts on the potentially curious EMPEROR-Reduced appearance on the November CHMP agenda.

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FIDELIO Demonstrates 18% RRR; DAPA-CKD and EMPEROR-Reduced Sub-Analyses

On the second day of Kidney Week 2020, three notable data sets were released: Bayer’s FIDELIO-DKD study demonstrated an 18% RRR in the primary composite endpoint (view press release; view NEJM publication); AstraZeneca presented a DAPA-CKD sub-analysis that demonstrated a reduction in the composite endpoint irrespective of the underlying CKD cause (view press release); BI/Lilly presented an EMPEROR-Reduced sub-analysis showing no difference in CV/renal outcomes regardless of baseline CKD (view press release). Below, FENIX provides highlights and implications of the data with a particular focus on FIDELIO.

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