Category Archives: GLP-1RA

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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Sanofi to Return Efpeg Rights To Hanmi

Sanofi has reportedly informed Hanmi of its intention to return efpeglenatide rights back to Hanmi. Hanmi noted that the two companies have 120 days to renegotiate the efpeglenatide deal at which point Hanmi said it may be open to taking legal action against Sanofi if needed. Below, FENIX provides insight into Sanofi’s decision, the potential impact on the efpeg development program, and why efpeg is still an attractive option for treating NASH/obesity.

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Semaglutide Ph3 Obesity Positive Topline Results (STEP 4)

Yesterday, Novo Nordisk announced positive results from the Ph3a STEP 4 trial evaluating the safety and efficacy of Semaglutide 2.4mg on body weight. Recall, STEP 4 is the first of the Ph3 semaglutide obesity program trials to read out. Below, FENIX provides an overview of the results as well as thoughts on potential readthrough to high-dose Ozempic.

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Ozempic Now Promoted on Victoza HCP Website

Novo Nordisk has recently updated the Victoza HCP website to include messaging for Ozempic. The first image on the Victoza HCP website landing page now states “Consider prescribing once-weekly Ozempic for your appropriate adult patients” with additional Ozempic messaging peppered throughout the Victoza HCP website. As of this publication, there has not been Ozempic messaging added to the Victoza patient website. Below, FENIX provides a brief overview of the Ozempic messaging on the Victoza HCP site as well as thoughts on Novo phasing out Victoza promotion during the COVID-19 pandemic.

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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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Thoughts on Sema NASH Ph2b Data

Novo Nordisk recently announced positive top-line results of its 72-week Ph2b NASH trial for semaglutide. Below, FENIX has conducted a winners-and-losers analysis in the context of Lilly, Sanofi, AZ, BI, and Lexicon, relative to the sema NASH results.

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Novo Q1 ’20 Earnings Roadshow; Xeris, Teva, and BD Earnings Updates

Novo Nordisk hosted its post-Q1 ’20 earnings roadshow event. Additionally, Xeris, Teva, and Becton Dickinson held their respective Q1 ’20 earnings calls. Teva did not discuss its generic liraglutide nor did BD discuss the status of its T2DM patch pump. Below, FENIX provides highlights and insights from the respective earnings calls.

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Semaglutide Positive Ph2 NASH Data; Novo Q1 ’20 Earnings Update

Novo Nordisk hosted its Q1 ’20 earnings call (press release; slides) and provided updates to its diabetes business including the ongoing launch of Rybelsus (oral semaglutide) and new Ph2 semaglutide NASH topline data. Unsurprisingly, much of the Q1 ’20 prepared remarks and Q&A were focused on NASH. Below, FENIX provides highlights from the call and additional thoughts on Novo’s PCSK9i/basal insulin hybrid approach.

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Sanofi Bs-Aspart Receives Positive CHMP Opinion; No Update on CREDENCE

According to the CHMP meeting highlights, Sanofi’s bs-aspart has received a positive CHMP opinion. Of note, the Invokana/Vokanamet renal protection indication (CREDENCE) was not mentioned in the meeting highlights, suggesting additional questions were asked to the sponsor. Below, FENIX provides brief thoughts on the positive CHMP opinion for Sanofi’s bs-aspart.

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CREDENCE and Sanofi’s Bs-Aspart up for CHMP Opinion; CHMP Agenda April 28-30

The CHMP agenda for this month’s meeting (April 28-30) has been released, and it includes two notable items up for CHMP opinion: Invokana/Vokanamet renal protection indication (CREDENCE) and Sanofi’s bs-aspart initial application. Of note, the April 2020 CHMP meeting agenda was just posted today despite the fact that the meeting started yesterday. Below, FENIX provides diabetes-related highlights and insights from the April 2020 CHMP agenda.

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