Tag Archives: Diabetes

AZ Triple Combo Approved as Qternmet XR; Qtern Label Update

AstraZeneca announced FDA approval for its triple combination, Qternmet XR (dapagliflozin+saxagliptin+metformin XR), for improvement of glycemic control in patients with T2DM (Qternmet XR FDA label). Additionally, the Qtern label (dapagliflozin+saxagliptin) was updated with 3 notable changes: 1) eGFR cutoff lowered to 45ml/min/1.73m2 which is now consistent with Farxiga, 2) a new 5mg dapa/5mg saxa strength is now available, and 3) the indication no longer requires dapa failure or concurrent use of dapa and saxa. Below, FENIX provides thoughts on the new triple combination FDC and Qtern label updates.

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Tresiba Hypo Benefit Over Toujeo; Novo Q1 ’19 Earnings Update

Novo Nordisk hosted its Q1 ’19 earnings call (press release) and provided updates to its diabetes business including the recent oral semaglutide and Ozempic regulatory filings. Of note, Novo reported topline results from the Tresiba vs. Toujeo H2H trial. Below, FENIX provides highlights and insights from the call including thoughts on how the Tresiba vs. Toujeo H2H trial may impact the basal insulin market.

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Insulet Q1 ’19 Earnings Update

Insulet hosted its Q1 ’19 earnings call and provided updates to its Omnipod business including the recent launch of the Omnipod Dash PDM as well as development of the Omnipod Horizon hybrid closed-loop. Below are highlights and insights from the call.

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Dexcom Q1 ’19 Earnings Update

Dexcom hosted its Q1 ’19 earnings call and provided updates to its diabetes business. Of note, this is believed to be the first time that Dexcom distributed slides as part of an earnings release. Below, FENIX provides highlights and insights from the earnings call.

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Tandem Q1 ’19 Earnings Update

Tandem hosted its Q1 ’19 earnings call and provided updates to its diabetes business including the Control IQ (hybrid closed-loop) and t:sport (with smartphone control) development programs. Below, FENIX provides highlights and insights from the call.

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Merck and Pfizer Q1 ’19 Earnings Updates

Merck and Pfizer hosted their respective Q1 ’19 earnings calls. Both companies only briefly discussed their diabetes-related businesses. Below, FENIX provides highlights from the calls.

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REWIND Filed; Empa T1DM, Nasal Glucagon Delayed; Lilly Q1 ’19 Earnings Update

Lilly hosted its Q1 ’19 earnings call and provided updates to its diabetes business. Of note, Lilly disclosed that it submitted REWIND (US and EU), URLi (EU, Japan, and maybe the US), a connected prefilled pen (US), and the empa+lina+metXR triple combination (US). Furthermore, Lilly also disclosed two regulatory delays. FDA refused to accept the sNDA for Jardiance in T1DM for “technical reasons,” and the review for Lilly’s nasal glucagon rescue product was extended by 3 months after FDA requested additional data. Below, FENIX provides thoughts and context to the significant Q1 ’19 regulatory events in diabetes.

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Victoza Pediatric Trial (ELLIPSE) Results and Regulatory Filings

Yesterday, Novo Nordisk presented results from the Victoza T2DM pediatric trial (ELLIPSE) at the Pediatric Endocrine Society/Pediatric Academic Societies annual meeting. Importantly, the results were published in the NEJM, which may be a testament to the growing attention on childhood T2DM/obesity. Additionally, Novo disclosed that it has submitted the data to US and EU regulators, although it did not specify the timing. Below, FENIX provides an overview of the ELLIPSE results – including the non-significant weight loss findings, and thoughts on the study in the context of Victoza’s impending LOE and recent settlement with Teva.

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Biocon CY Q1 ’19 (FY Q4 ’19) Earnings Update

Biocon hosted its CY Q1 ’19 (FY Q4 ’19) earnings call and briefly discussed its biosimilar insulin program including bs-glargine and bs-aspart. Below, FENIX provides highlights and insights from the call.

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