Category Archives: GLP-1RA

Thoughts on New ACC T2DM ASCVD Recommendations

The ACC published their 2018 ACC Expert Consensus Decision Pathway on Novel Therapies for CV Risk Reduction in Patients with T2DM and ASCVD in JACC. Notably, the ACC recommends SGLT2i use for potential CV benefits and GLP-1RA use for those patients who may have an unsuitable risk profile for SGLT2i use. Below, FENIX provides a winners-and-losers analysis based on the recent ACC recommendations compared to the updated ADA/EASD guidelines from October 2018.

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Thoughts on PIONEER-6 Results

On Friday, Novo Nordisk announced positive top-line results from the oral semaglutide CVOT, PIONEER-6. Although PIONEER-6 did not meet superiority for 3P-MACE, Novo reported statistically significant (ss) ~50% RRRs for CV death and all-cause mortality. Below, FENIX discusses the likelihood for the semaglutide franchise to receive a CV risk reduction indication in the context of the somewhat divergent PIONEER-6 results, a description of different filing scenarios against Lilly characterized as high likelihood, low likelihood, and “power move”, what an FDA adcom could look like, and finally, external factors of influence. PIONEER-6 consistency check Below is a table comparing the results……

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Thoughts on the Regulatory Environment in Diabetes

The regulatory environment in diabetes has greatly evolved in the last 10 years since the 2008 FDA CV risk guidance. As recently as ADA and now through EASD in 2018, FENIX considers the regulatory environment in the US and Europe to be highly favorable for sponsors developing diabetes drugs, devices, and technological solutions. Below, FENIX provides its perspective in a winners and losers analysis on how the highly favorable regulatory environment could be positively impactful to the key upcoming 2019 market events in diabetes from sponsors like Lexicon, Sanofi, AZ, Janssen, Novo Nordisk, Xeris, Lilly, BI, Dexcom, Senseonics, Abbott/Bigfoot, Tandem, Insulet, and Medtronic.

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Farxiga T1DM US Filing in Q4 ’18; AZ Q3 ’18 Earnings Update

AZ hosted their Q3 ’18 earnings call (press release) and briefly discussed their diabetes portfolio. Of note, AZ disclosed it plans to file Farxiga for a T1DM indication in Q4 ’18. Previously, AZ had been quiet regarding the US Farxiga T1DM filing during Q2 ’18 earnings. Furthermore, full results from the Farxiga CVOT, DECLARE, are being presented at the AHA conference on November 10, 2018. Below, FENIX provides thoughts on the potential DECLARE indication, Farxiga T1DM filing timing, and other highlights from the call. Farxiga CVOT (DECLARE) Filing Given the upcoming DECLARE data presentation at AHA, AZ senior management only……

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REWIND Safety Issue? Lilly Q3 ’18 Earnings Update

Lilly hosted its Q3 ’18 earnings call and provided updates to its diabetes business including commentary on the recent REWIND topline results. Of note, Lilly’s first Ph3 study for its GIP/GLP dual agonist, now called tirzepatide, has been posted on CT.gov. Furthermore, Lilly said it has purchased a priority review voucher (PRV), but did not disclose how it will be used. Below, FENIX provides its new thoughts on REWIND safety, why Lilly’s PRV would be used for REWIND, and other key highlights from the earnings call.

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Positive Trulicity CVOT Creates Many Market Implications

Lilly announced positive topline results from the Trulicity CVOT, REWIND, demonstrating a reduction in 3P-MACE in a patient population which included ~70% primary prevention. Of note, Lilly did not provide any Hazard Ratios so the amount of CV protection remains unclear. Below, FENIX provides thoughts on the potential impact to guidelines and the GLP-1RA market if FDA grants a broader CV indication (reduction in 3P-MACE in T2DM patients with CV risk factors) than the Victoza, Jardiance, and Invokana labels.

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Novo Q3 ’18 London Earnings Event

Novo Nordisk hosted its post-Q3 ’18 earnings event in London. The session was primarily comprised of Q&A with topics including high dose Ozempic as well as an update on Novo’s priority review voucher. Below are highlights from the call.

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Novo to Pursue High-Dose Ozempic for T2DM; Q3 ’18 Earnings Update

Novo Nordisk hosted its Q3 ’18 earnings call (press release) and provided updates to its diabetes business. Below are highlights from the call including Novo’s disclosure that it is pursuing high-dose Ozempic (2.4 mg) in T2DM to maintain best-in-class status ahead of Lilly’s anticipated GIP/GLP-1 dual agonist launch projected in 2023. Additionally, Novo has discontinued development of its Hypopen-1513, a glucagon rescue product for the treatment of hypoglycemia.

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Sanofi Q3 ’18 Earnings Update

Sanofi hosted its Q3 ’18 earnings call (press release) and provided updates on its diabetes and CV business unit including perspective on the recent restructuring announcement (previous FENIX insight). Additionally, Sanofi discussed its 2019 managed care outlook for Lantus, Toujeo, Admelog, and Praluent (PCSK9i). Below are highlights from the call. Financial Highlights Q3 ’18 WW diabetes sales decreased by -9.2% YOY to €1.37B, primarily driven by declining US glargine sales. US diabetes sales for the same quarter also declined by -24.3% YOY to €571M reflecting changes in Medicare Part D (MPD) coverage and declining US glargine net prices. Of note,……

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