Category Archives: GLP-1RA

Novo to File Oral Sema with PRV; Q4 ’18 Earnings Update

Novo Nordisk hosted its Q4 ’18 earnings call and disclosed that it will use its priority review voucher (PRV) for the oral semaglutide US filing by the end of Q1 ’18. Of note, Novo is planning to file for Ozempic and oral semaglutide CV indications based on the results from SUSTAIN 6 and PIONEER 6 despite PIONEER 6 not achieving statistical significance for 3P-MACE. Below, FENIX provides highlights from the earnings call, additional insight on the semaglutide regulatory strategy, and thoughts on why Novo likely wants an oral semaglutide adcom.

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New Ozempic Renal Outcomes Study (FLOW)

Novo has initiated a new renal outcomes trial for Ozempic called “FLOW.” Below, FENIX provides thoughts on the trial in the context of LEADER (Victoza) and SUSTAIN 6 (Ozempic) results. Additionally, FENIX constructed a renal outcomes comparison table including the GLP-1RA and SGLTi classes.

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New Semaglutide Retinopathy Study Called FOCUS

A new study evaluating the effect of semaglutide on retinopathy in T2DM, called “FOCUS,” has been posted on CT.gov. Recall, data from Novo’s SUSTAIN 6 study showed an imbalance in retinopathy with a 1.76 hazard ratio (50 events with sema vs. 29 with placebo) which resulted in a label warning. Below, FENIX provides details from the study as well as thoughts on how Novo will leverage the data.

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Oramed Initiates Ph1 Oral GLP-1RA; Zafgen and vTv Ph2 data

Oramed has initiated its first ORMD-0901 (oral GLP-1RA) Ph1 study under its FDA IND application. Additionally, Zafgen and vTv Therapeutics recently announced data from their respective Ph2 programs for ZGN-1061 (MetAP2 inhibitor) and TTP399 (glucokinase activator). Below, FENIX provides an overview of the Oramed Ph1 study, Zafgen and vTv Ph2 data, and thoughts the viability of each program in the antihyperglycemic market. Oramed Ph1 Oral GLP-1RA initiation Oramed announced the initiation of its first Ph1 study under their FDA IND application. Recall, The IND was granted in September 2018. According to the press release, the Ph1 trial is a randomized, single-blinded crossover……

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New Trulicity Label Update: lower hypo cutoff, AWARD-10, and pre-filled syringe discontinuation

The Trulicity label has recently been updated with 3 major changes: 1) lower rates of hypoglycemia based on moving the cutoff from <70mg/dL to <54mg/dL, 2) inclusion of AWARD-10 data (add-on to SGLT2i), and 3) discontinuation of the pre-filled syringes. Below, FENIX provides analysis of the Trulicity label update including a focus on the broader market implications of lowering the hypo cutoff. Trulicity hypo label data improves competitive messaging vs. Ozempic The Trulicity label was updated with new, lower hypo rates using a lower hypo cutoff to match Ozempic and Bydureon. In the old Trulicity label, the cutoff was high……

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JPM 2019 Day 2: LLY, SNY, LXRX, ABT, PODD, MYL

The second day of the 2019 J.P. Morgan Healthcare conference included diabetes-related presentations from Lilly, Sanofi, Lexicon, Mylan, Abbott, and Insulet. Separately, Lilly announced plans to further increase drug pricing transparency using Trulicity TV DTC. The commercials will include a portion directing patients to a Lilly website for more information on list price and average copays. Below, find a topline summary of key JPM takeaways by company followed by more in-depth coverage. In case you missed it, here is a link to FENIX’s Day 1 JPM 2019 insights. Lilly Lilly’s CEO provided a brief introduction to the company and referenced the……

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Thoughts on 2019 ADA Standards of Care

The ADA announced the publication of their 2019 Standards of Medical Care in Diabetes Care. Of note, the ADA has aligned their CVD recommendations with the ACC’s recent T2DM ASCVD recommendations. The ADA also added a new dedicated section titled “Diabetes Technology,” which includes information previously incorporated in the “Glycemic Targets” section. The ADA also provides a cost breakdown of pharmacologic treatment options. Below, FENIX has provided highlights and insights from the updated ADA 2019 Standards of Care.

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Lilly 2019 Guidance Summary

Today, Lilly hosted its 2019 Guidance and Investment Community Meeting and discussed potential key milestones for 2019. Importantly, Lilly announced late stage development plans in obesity and NASH and provided more information on the Ph3 dose titration for its QW injectable GIP/GLP-1 dual agonist tirzepatide. Connected care was also featured, and several comments were made on guidelines updates and new PBM coverage positively affecting Trulicity and Jardiance in 2019. Below, FENIX provides a summary and thoughts on diabetes-related highlights from the event.

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Intarcia re-filing mid-2019

Yesterday, Intarcia announced a corporate update, where the main news was that it intends to re-submit the ITCA-650 NDA in “mid-2019”. The announcement also quoted its three new senior team members, including Fred Fiedorek as Chief Medical Officer and Head of Regulatory (previous FENIX insight), Thane Wettig as Chief Marketing Officer (previous FENIX insight), and Anders Vinther as Global Head of Quality & Engagement. Intarcia’s 2017 CRL was well-publicized (previous FENIX insight), but Intarcia has seemingly been given a path to re-filing “…after several consultations with the FDA during 2018…”. If Intarcia re-files in June, it should have a PDUFA date……

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New Sanofi and Dexcom trials: Efpeglenatide add-on to MET+/-SU and G6 vs. Libre FGM

Recently, FENIX has observed new Sanofi and Dexcom trials on CT.gov. Sanofi has posted its Ph3 efpeglenatide trial (AMPLTITUDE-S) as an add-on to metformin (MET) with or without sulfonylurea (SU). Additionally, Dexcom has an investigator-initiated trial comparing the G6 CGM with Libre FGM in T1DM (ALERT-T1). Below, FENIX provides thoughts on the respective studies, as well as a comparison of GLP-1RA trials with MET+/-SU. Sanofi Efpeglenatide Ph3 study as an add-on to MET±SU (AMPLTITUDE-S) Sanofi has initiated AMPLITUDE-S for its QW GLP-1RA, efpeglenatide, as an add-on to MET±SU. Of note, this is the last pivotal study for efpeglenatide regulatory submission, anticipated to……

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