SGLT latecomer Lexicon gets heart failure okay

Lexicon Pharma tried and failed to get FDA approval for its SGLT inhibitor sotagliflozin for diabetes, but it has finally got the drug over the finish line – for a different indication altogether.

The FDA has approved the SGLT1 and SGLT2 inhibitor Inpefa as a once-daily oral therapy that can be used across a broad range of patients with or at risk of heart failure, including those with reduced and preserved ejection fraction and with or without diabetes.

Specifically, it has been cleared to lower the risk of cardiovascular death, urgent heart failure visit, and hospitalisation for heart failure in adults with heart failure or chronic kidney disease, type 2 diabetes mellitus, and other cardiovascular risk factors.

It’s a broad label that gives Lexicon a shot at carving out a niche for Inpefa among other SGLT-directed therapies for heart failure, including Eli Lilly/Boehringer Ingelheim’s Jardiance (empagliflozin) and AstraZeneca’s Farxiga (dapagliflozin), both selective SGLT2 inhibitors.

Inpefa is the company’s first approved product, and has been greenlit based on data from two phase 3 cardiovascular outcomes trials – SOLOIST-WHF and SCORED – which together enrolled around 12,000 patients.

In the SOLOIST-WHF trial, which included patients recently hospitalised for worsening heart failure, Inpefa cut the risk of hospitalisations for heart failure, cardiovascular death, and urgent visits for heart failure by 33% compared to placebo.

“The approval of INPEFA, along with the breadth of the label, is a major milestone in Lexicon’s path to fulfilling its mission of pioneering medicines that transform patients’ lives,” said Lonnel Coats, the biotech’s chief executive.

“We expect this important innovation to be commercially available in the US market by the end of June,” he added. There’s no word yet on the price Lexicon intends to charge for the drug, although the company is due to hold a conference call tomorrow to lay out its plans for commercialisation.

Lexicon’s attempt to get approval for sotagliflozin as an add-on to insulin therapy for people with type 1 diabetes resulted in a complete response letter (CRL) from the FDA in 2019, on the grounds that it came with a risk of diabetic ketoacidosis (DKA).

The decision was appealed twice by the company without success, and in the interim it lost a multibillion-dollar alliance with Sanofi for the drug. It did manage to get approval for type 1 diabetes indication in Europe as Zynquista, however, but was never launched there for commercial reasons.

Piper Sandler analysts predicted ahead of the approval earlier that Inpefa could generate sales of $112 million in 2025, rising to $576 million by 2028.