Cardiology Pharmaceuticals

Lexicon’s Lands Long-Awaited HF Approval

Lexicon Pharmaceuticals’ Inpefa (sotagliflozin) just became the first FDA-approved dual SGLT2 / SGLT1 inhibitor for treating heart failure, landing a wide-ranging approval that could alter the HF treatment arena.

The once-daily pill is approved for risk reduction of cardiovascular death, heart failure hospitalization, and urgent heart failure ED visits among all adults with HF — regardless of their diabetes status or left ventricular ejection fraction range (including HFpEF and HFrEF). 

  • Inpefa also uniquely inhibits SGLT1 (responsible for glucose absorption in the GI tract) and SGLT2 (responsible for glucose reabsorption by the kidney).

Inpefa’s approval for such a broad range of patients is largely supported by the results of two Phase 3 trials:

  • The SOLOIST-WHF trial showed that sotagliflozin reduced the risk of CV death, HF hospitalization, and urgent HF visits by 33% compared to placebo
  • In the SCORED study, sotagliflozin similarly reduced the composite risk of CV deaths, HF hospitalizations, and urgent HF visits (HR 0.74).
  • The trials also showed that sotagliflozin might uniquely improve glycemic control at lower GFRs, while reducing risk of stroke and nonfatal heart attacks.

Still, sotagliflozin’s path towards FDA approval was far from easy, including a 2019 rejection for treating Type 1 diabetes (that prompted Sanofi to terminate their partnership) and Lexicon’s 2022 decision to temporarily rescind its FDA application for treating HF in patients with Type 2 diabetes. 

Lexicon’s regulatory perseverance should pay off commercially when Inpefa launches later this month, which with the help of a new $125M public stock offering, would likely drive a massive surge in sales (compared to its $139k in 2022 revenue, anyway).

Inpefa will face plenty of SGLT2 competition from AstraZeneca’s Farxiga (dapagliflozin) and Eli Lilly and Boehringer Ingelheim’s Jardiance (empagliflozin), which brought in a combined $10.6B last year, perhaps placing more emphasis on Inpefa’s unique ability to also inhibit SGLT1.

HF advocates will also be monitoring whether the introduction of a third HF medication might create enough competition to drive down SGLT2 medication costs and boost still-lagging adoption. That said, Lexicon plans to start Inpefa with pricing “comparable to existing heart failure medications,” so they shouldn’t expect any immediate reductions.  

The Takeaway

Cardiology’s red hot heart failure care segment just added its third medication covering all HF patients, and its first supporting both SGLT1 and SGLT2 inhibition. That could be a big deal for HF patients and clinicians in search of more treatment options (and eventually more reasonable costs), and for Lexicon Pharmaceuticals’ commercial ambitions.

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