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An SGLT2 windfall? Heart failure gold rush likely to benefit diabetes players: analyst

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When the FDA approved Eli Lilly and Boehringer Ingelheim’s Jardiance as a heart-helping addition for heart failure patients, it kicked off an arms race in the SGLT2 class. That war for supremacy isn’t without reason: The heart failure market is set for a gold rush in the coming years, and it could spell blockbuster sales for drugmakers that stake a claim.

Powered by a booming slate of SGLT2 cardiovascular approvals, the U.S. heart failure market is set to grow by sevenfold in the coming decade from $3.7 billion in 2018 to $22.1 billion in 2028, according to GlobalData. 

What will spur that boom? The rising prevalence of heart failure co-morbidities like diabetes, for one, but also a rapidly aging population and a rising need for treatments following a heart attack. 

According to GlobalData, a booming market will not only benefit meds like AstraZeneca’s Farxiga and Eli Lilly and Boehringer Ingelheim’s Jardiance––both of which sport heart-helping labels––but also a range of generic medicines, including statins, currently used as standard of care for heart failure patients. 

“The exciting growth seen in the HF market will be largely due to SGLT inhibitors,” GlobalData analyst Heather Farrell said in a release. “Their trial results in reducing mortality and risk of hospitalization are unmatched, so far, and the familiarity of the drugs as anti-diabetics will hopefully improve the uptake and optimize dosing strategies.”

When the FDA gave the SGLT2 class its first entry into heart failure after Jardiance’s approval in 2015, it kick-started a heated competition in the space that is still going today.

The most recent trendsetter in the group, Farxiga, is awaiting an FDA priority review for its application to treat heart failure patients with or without Type 2 diabetes––a first-in-class approval that would likely change the direction of the field as a whole.

Farxiga is currently approved to reduce the risk of hospitalizations in heart failure patients with a reduced ejection fraction (HFrEF) and Type 2 diabetes, as well as solo and combo approvals in diabetes proper. 

RELATED: AstraZeneca’s Farxiga nabs first CV approval from the FDA. Will a bigger one follow?

The heart failure nod, granted in October, was based on outcomes trial data showing Farxiga cut the rate of hospitalizations by 36% among HFrEF patients and by 24% among those without one. Farxiga already sports those benefits on its label in Europe, where it’s known as Forxiga.

Farxiga previously trailed SGLT2 rivals like Johnson & Johnson’s Invokana and Eli Lilly and Boehringer Ingelheim’s Jardiance in marketing cardiovascular benefits but will take a major step ahead of both if it nabs this newest FDA green light.

The priority review comes on top of a fast-track designation Farxiga scored in September on the heels of trial data showing it cut CV risks by 26% when added to standard-of-care therapy for heart failure patients with or without Type 2 diabetes as part of its Dapa-HF outcomes trial.

RELATED: Novo’s Ozempic scores major win with heart-helping FDA approval. Is Rybelsus next?

GlobalData’s report not only singled out SGLT2 meds as possible market drivers in the coming years but also novel treatments like Bayer and Merck & Co.’s sGC enzyme simulator vericiguat. The med hit its primary endpoint in a phase 3 trial in November despite missing the mark in the two phase 2 studies that preceded it.

Novo Nordisk’s Ozempic, a diabetes fighter in the GLP-1 class, also recently scored an FDA approval to reduce the risk of CV events in heart failure patients with diabetes. The agency based its decision on Novo’s CV outcomes study, dubbed Sustain 6, that showed patients treated with Ozempic posted a 26% relative risk reduction over placebo in preventing CV events, including death, non-fatal heart attacks and non-fatal strokes.

Ozempic, initially approved in December 2017 as a treatment for diabetes, launched in early 2018 and has since raced out to blockbuster status. In the first nine months of 2019, Ozempic posted DKK 6.87 billion ($1 billion) in global sales.

Novo’s other next-gen GLP-1, oral med Rybelsus, is under study as a CV preventative in patients with Type 2 diabetes as part of Novo’s Soul CVOT study launched in June. Rybelsus, approved in September with blockbuster aspirations, is expecting a label decision on its CV benefit as early as the first quarter, the company said.

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