Endocrinology Month in Review: August 2024

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The endocrinology month in review for August 2024 spotlights 6 pieces of major pipeline news or regulatory announcements as well as multiple episodes of Diabetes Dialogue.

The landscape of cardiometabolic health has been defined by innovation and breakthroughs for the last decade, with the fields of diabetes management and endocrinology the source of a considerable degree of this advancement. With August 2024 now in the rearview, it's clear this trend is likely to continue, with the month a slew of noteworthy regulatory news and announcements. In our endocrinology month in review, we highlight 6 pieces of pipeline or regulatory news as well as 3 episodes of our flagship endocrinology podcast Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives.

FDA and Pipeline News

Tirzepatide Reduces Heart Failure Outcomes in Obesity-Related Heart Failure

On August 01, 2024, Eli Lilly and Company announced positive topline data from the phase 3 SUMMIT trial, evaluating tirzepatide in adults with heart failure with preserved ejection fraction (HFpEF) and obesity. The study demonstrated that tirzepatide, a dual GIP/GLP-1 receptor agonist, significantly improved both primary endpoints, showing a 38% relative risk reduction in time-to-first occurrence of heart failure outcomes over 104 weeks compared to placebo (Hazard Ratio [HR], 0.62; 95% confidence interval [CI], 0.41 to 0.95; P = .026). The trial also found significant improvement in heart failure symptoms and physical limitations, as measured by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score, with a mean change from baseline of 24.8 points for tirzepatide versus 15.0 for placebo at week 52.

Additional analyses highlighted significant secondary endpoint improvements in exercise capacity, measured by the 6-Minute Walk-Test Distance, reductions in high-sensitivity C-reactive protein, and a mean body weight reduction of 15.7% with tirzepatide compared to 2.2% with placebo at 52 weeks. Eli Lilly plans to submit the SUMMIT results to the FDA and other regulatory agencies later in 2024.

Finerenone Makes Case for GDMT in HFpEF with FINEARTS-HF

On August 04, 2024, Bayer announced topline results from the FINEARTS-HF trial and the trial was presented at the European Society of Cardiology (ESC) Congress 2024. Results indicates finerenone (Kerendia) could emerge as a second pillar of guideline-directed medical therapy for heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF). The trial, a phase 3, international, double-blind, randomized study, enrolled 6016 patients with New York Heart Association class II to IV heart failure and an LVEF of 40% or greater, who were randomized to finerenone or placebo and followed for up to 42 months.

Results indicated finerenone use was associated with a statistically significant 16% reduction in the rate of the primary composite endpoint of cardiovascular death and total heart failure events (rate ratio [RR], 0.84; 95% CI, 0.74 to 0.95; P = .007). Specifically, there was an 18% relative reduction in heart failure hospitalization (RR, 0.82; 95% CI, 0.71 to 0.94; P = .006), but no significant reduction in cardiovascular death (HR, 0.93; 95% CI, 0.78 to 1.11).

Medtronic Secures FDA Approval for Simplera CGM, Partners with Abbott

On August 7, 2024, the FDA approved the Simplera continuous glucose monitor (CGM) from Medtronic, marking the company’s first disposable, all-in-one CGM device that is half the size of previous models. This approval coincided with the announcement of a global partnership between Medtronic and Abbott to develop integrated CGM options for individuals with diabetes. The collaboration will focus on a CGM based on Abbott’s platform, which will work exclusively with Medtronic's smart dosing devices and software.

The Simplera CGM is designed to be used with the InPen smart insulin pen as part of a Smart MDI system and integrated with the MiniMed 780G system. While the Simplera Sync sensor is still under FDA review, the Simplera CGM has already been launched in Europe, receiving positive feedback for its ease of use and insertion.

This partnership aims to expand access to advanced insulin delivery and monitoring systems, providing more choices for people living with diabetes through a seamless Medtronic experience.

FDA Approves Palopegteriparatide for Hypoparathyroidism

On August 12, 2024, the FDA approved palopegteriparatide (YORVIPATH®), developed as TransCon PTH by Ascendis Pharma, for the treatment of hypoparathyroidism in adults. The approval was based on the review of the New Drug Application, including data from the Phase 2 PaTH Forward and Phase 3 PaTHway trials, which demonstrated that 79% of patients treated with palopegteriparatide achieved the primary endpoint of normal serum calcium levels and independence from conventional therapy, compared to 5% in the placebo group (P <.0001). Palopegteriparatide is a prodrug of parathyroid hormone (PTH) designed to provide continuous PTH exposure over 24 hours, addressing the underlying cause of hypoparathyroidism.

Following a Complete Response Letter from the FDA in May 2023 due to concerns related to the manufacturing control strategy, Ascendis resubmitted the NDA in December 2023, leading to the eventual approval of the therapy. Palopegteriparatide will be supported by the US Ascendis Signature Access Program, which includes patient services and financial assistance for eligible individuals with hypoparathyroidism.

Dexcom Announces Availability, Pricing of Stelo—First OTC Glucose Sensor

On August 26, 2024, Dexcom launched Stelo, the first FDA-cleared over-the-counter (OTC) glucose sensor available in the US, retailing for as low as $89.99 for a 2-pack on Stelo.com. Designed for a 15-day wear time, Stelo is offered through pay-as-you-go or subscription models, with pay-as-you-go customers paying $99 for a 2-sensor pack for up to 30 days of use, and subscribers saving 10% with an $89 monthly subscription. The sensor is eligible for HSA/FSA use.

Stelo, cleared by the FDA on March 5, 2024, is intended for individuals 18 years and older who do not use insulin, including those managing diabetes with oral medications or individuals without diabetes seeking to understand blood sugar responses to diet and exercise. Dexcom highlights Stelo’s features, including its design for fingerstick-free use, a high waterproof rating, real-time glucose variability detection, and a personalized app for tracking glucose trends.

Stelo is the first of three OTC glucose sensors cleared in 2024, followed by Abbott’s Lingo and Libre Rio on June 10, designed for general health monitoring and type 2 diabetes management without insulin, respectively.

FDA Clears Omnipod 5 AID System for Type 2 Diabetes

On August 26, 2024, the FDA expanded indications for Insulet Corporation’s SmartAdjust technology, approving the Omnipod 5 Automated Insulin Delivery (AID) System for adults with type 2 diabetes, making it the first AID system cleared for both type 1 and type 2 diabetes management. This decision was supported by data from the SECURE-T2D study, presented at the 84th American Diabetes Association Scientific Sessions, which demonstrated significant improvements in glycemic control among type 2 diabetes patients using Omnipod 5.

SECURE-T2D enrolled 305 adults with type 2 diabetes, aged 18 to 75, who had been on insulin for at least three months without prior AID use. After a 14-day standard therapy period, participants used the Omnipod 5 AID system with the Dexcom G6 CGM for 13 weeks. Results showed a reduction in mean HbA1c from 8.2% at baseline to 7.4% (treatment effect = -0.8%; 95% CI, -1.0 to -0.7; P < .001). Secondary metrics indicated a 20% increase in time in range (70-180 mg/dL) and a 20% reduction in time above 180 mg/dL, with improvements driven by reduced hyperglycemia without increased hypoglycemia.

The FDA's clearance aims to broaden access to advanced diabetes management tools, supporting millions of US adults with type 2 diabetes.

Diabetes Dialogue

In addition to the 3 episodes on FDA and pipeline news featured above, August featured 3 additional episodes of HCPLive Endocrinology’s flagship diabetes podcast. IN these episodes, which are highlighted below, hosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, tackle a variety of topics from the Association of Diabetes Care and Education Specialists (ADCES) 2024 annual meeting, resubmission of sotagliflozin for type 1 diabetes, and a reaction to list price announcements from the first 10 drugs chosen for negotiation as part of the Inflation Reduction Act.

Diabetes Dialogue: Navigating ADCES 2024

The first of 2 episodes on ADCES 2024, this episode focuses on sessions and presentations hosts Isaacs and Bellini participated in during the meeting.

Diabetes Dialogue: Sotagliflozin for T1D and Other ADCES 2024 Highlights

This episode focuses on Lexicon Pharmaceutical’s resubmission of sotagliflozin in type 1 diabetes. In the second half of the episode, hosts discuss topics related to the ADCES 2024 annual meeting.

Diabetes Dialogue: First 10 Prices Announced from CMS Price Negotiations

In this episode, hosts react to the announced CMS list prices for the first 10 drugs chosen for negotiation as part of the Inflation Reduction Act.

Full episode below:

Relevant disclosures for Isaacs include Eli Lilly and Company, Novo Nordisk, Sanofi, Abbott Diabetes Care, Dexcom, Medtronic, and others. Relevant disclosures for Bellini include Abbott Diabetes Care, MannKind, Provention Bio, and others.