Tag Archives: Novo Nordisk

High-Dose Ozempic Filed with FDA; Andy Ajello Joins Vifor

Novo Nordisk announced it has filed the sNDA for high-dose Ozempic (2.0mg) based on results from the SUSTAIN FORTE trial, which read out in November 2020 (previous FENIX insight). Additionally, Andrew (Andy) Ajello, former Lexicon Commercial Lead and Novo SVP of US Diabetes/Obesity Sales, has joined Vifor Pharma as the VP of US sales (view LinkedIn profile). Below, FENIX provides thoughts and insights on the respective news items.

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JPM 2021 Day 3: Bayer, Esperion, Precision Bio, Hikma, Vifor; High-dose Oral Sema PIONEER PLUS Trial Posted on CT.gov; Dario Announces Two New Additions to Scientific Advisory Board

On day three of JPM 2021, FENIX has provided coverage of presentations from Bayer, Esperion, Precision Biosciences, Hikma, and Vifor. Additionally, two separate cardiometabolic-related news items have been observed: a CT.gov record has been observed for Novo Nordisk’s PIONEER PLUS trial investigating high-dose oral semaglutide in people with T2DM; and DarioHealth announced Marilyn Ritholz and David Horwitz will be joining the Scientific Advisory Board. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage.

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JPM 2021 Day 2: LLY, NVO, ABT, PODD, AMRN, and IONS; Bayer’s Finerenone Receives Priority Review for DKD

On day two of JPM 2021, FENIX has provided coverage of presentations by Lilly, Novo Nordisk, Abbott, Insulet, Amarin, and Ionis. Additionally, one separate cardiometabolic-related news item has been observed: Bayer announced FDA granted priority review of finerenone for patients with DKD. Below, FENIX provides a topline summary of key takeaways followed by more in-depth coverage.

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Novo Selects First Liver Therapy From Dicerna Collab; Metacrine Initiates Ph2a Jardiance Combo Trial in T2DM/NASH; Terns Pharma Raises $87M in Series C Funding; Dario Announces First Self-insured Employer Client

A series of cardiometabolic-related news items have been observed: Dicerna announced Novo Nordisk selected its first GalXC RNAi candidate for IND-enabling studies in liver-related cardiometabolic diseases; Metacrine announced the initiation of a Phase 2a combination trial of MET409 50g with empagliflozin in patients with T2DM and NASH; Terns Pharmaceuticals announced the closing of its Series C funding round with $87M raised for NASH-related trials; Dario announced an agreement with the first self-insured employer group to come from its partnership with Vitality Group. Below, FENIX provides highlights and insights for the respective news items.

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Holiday Hangover: FDA Approves First Generic Glucagon; Novo High-dose Sema EU Filing; Novo Extends COVID-19 Relief Program; Eversense Implantable CGM Delayed by FDA; Provention Bio’s Teplizumab Filing Accepted by FDA; Teplizumab July 2, 2021 PDUFA

During the holiday break, a series of diabetes-related news items were observed from Amphastar, Novo Nordisk, Senseonics, and Provention Bio. Below, FENIX provides highlights and insights for the respective news items.

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Novo Files Sema 2.4mg Obesity Indication with EMA

Novo Nordisk announced it has filed the MAA for the semaglutide 2.4mg obesity indication in Europe. Recall, Novo filed sema 2.4mg for obesity with FDA on December 4, 2020. Below, FENIX provides additional insight with regard to the European obesity market.

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Novo Partners with Procyon Technologies for T1DM Stem-Cell Treatment; Bigfoot Expands Commercial Leadership Team; JDRF and Provention Bio Launch T1DM Screening Campaign; New Arecor Trial for Ultra-concentrated RAI; City of Hope Initiates Ph1 T1DM Vaccine Trial

A series of diabetes-related news items have been observed: earlier this week, Procyon Technologies LLC announced it has entered into a partnership with Novo Nordisk for the development of an implantable cell encapsulation device to be combined with Novo’s stem cells for the treatment of T1DM; Bigfoot Biomedical announced new hires within the company to build out its commercial team ahead of the Bigfoot Unity US launch; JDRF and Provention Bio announced the launch of T1Detect, a T1DM screening campaign; a clinical trial has been observed for AT278, Arecor’s ultra-concentrated rapid-acting insulin aspart; and City of Hope announced enrollment has opened for a Ph1 T1DM vaccine trial. Below, FENIX provides highlights and insights for the respective news items.

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Thoughts on Pediatric Exclusivity for Saxenda and Januvia

Two diabetes-related news items have been observed: late last week, FDA approved Saxenda for the treatment of obesity in adolescents (view press release); and FDA issued a press release stating the Januvia franchise has not been proven to improve glycemic control in pediatric patients (ages 10-17) with T2DM (view updated Januvia label). Below, FENIX provides thoughts on how the label updates are anticipated to impact the respective brands.

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Novo Retracts CONCLUDE (H2H Tresiba vs. Toujeo) Press Release

Novo Nordisk announced the Danish Maritime and Commercial High Court ruled Novo’s September 19, 2019 press release regarding the full results from the CONCLUDE trial (H2H Tresiba vs. Toujeo in T2DM; view original press release here) violated the Danish Marketing Practices Act and the Danish Medicines Act. However, Novo did not disclose which specific portion of the September 2019 press release was in violation. In case you missed it, here is a link to FENIX’s insight on the CONCLUDE result following the presentation at EASD 2019.

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SUSTAIN FORTE Topline Results: Ozempic 2.0mg Doubles the Dose but not the Efficacy

Novo Nordisk announced topline results from its high-dose injectable semaglutide Ph3 study, SUSTAIN FORTE. The study demonstrated a -2.2% reduction in A1C and -6.9kg weight loss with 2.0mg semaglutide according to the trial product estimand (e.g. per-protocol analysis). Below, FENIX provides a SUSTAIN FORTE comparative analysis, including thoughts on high-dose Ozempic in the context of high-dose Rybelsus, high-dose Trulicity, and tirzepatide, as well as updated perspective on the regulatory timing for Novo’s sema obesity submission with its PRV.

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