After FDA Miss in Diabetes, Lexicon Lands Long-Awaited Approval in Heart Failure

After FDA Miss in Diabetes, Lexicon Lands Long-Awaited Approval in Heart Failure
After FDA Miss in Diabetes, Lexicon Lands Long-Awaited Approval in Heart Failure

A Lexicon Pharmaceuticals drug that failed to secure FDA approval in type 1 diabetes under a partnership with Sanofi is now approved as a heart failure therapy. The regulatory nod puts the Lexicon pill in competition with medicines marketed by AstraZeneca and partners Eli Lilly and Boehringer Ingelheim.

Approval of the drug, sotagliflozin, covers adults who have had heart failure and are at risk of developing it again. It also covers the reduction of heart failure risk in adults with type 2 diabetes, chronic kidney disease, or other cardiovascular risk factors. Lexicon, based in The Woodlands, Texas, will commercialize its new drug under the brand name Inpefa.

Inpefa follows a path blazed by drugs that block sodium-glucose co-transporter type 2 (SGLT2), a protein that enables kidneys to absorb glucose. By blocking this protein, SGLT2 inhibitors lead to glucose being excreted in the urine. First approved as treatments for diabetes, this drug class has two therapies that have secured additional approvals in heart failure: Farxiga from AstraZeneca and Jardiance from Lilly and Boehringer Ingelheim.

Lexicon executives believe Inpefa matches up favorably against both blockbuster products. While Inpefa is the third SLGT2 inhibitor approved for heart failure, Lexicon CEO Lonnel Coats said his company’s drug is the only one whose approval specifically includes the treatment of patients in transition from hospitalization to outpatient care.

“Inpefa’s broad label means that we have the ability to compete across the entire spectrum of heart failure patients,” Coats said, speaking during a Tuesday conference call. “However, our primary focus will be on the sweet spot of care, which for us is the transition-of-care patient. We believe that patients who are stabilized following hospitalization for heart failure are perfect candidates to be considered for Inpefa before leaving the hospital or soon thereafter.”

In addition to blocking SLGT2, Inpefa also blocks SGLT1, a protein that’s responsible for glucose absorption in the kidney. Lexicon discovered and developed the small molecule, advancing it to Phase 3 testing in type 1 diabetes. In 2015, Sanofi began a collaboration on the drug, paying $300 million up front to gain global rights to the molecule. Lexicon continued to be responsible for the drug’s clinical development.

In early 2019, the FDA turned down Lexicon’s application seeking approval of the molecule as a treatment for a type 1 diabetes. Later that year, Lexicon and Sanofi agreed to terminate the collaboration, and all rights to the molecule reverted to the biotech. Lexicon appealed the FDA’s rejection of the drug twice, but was denied both times. The drug did go on to win approval in Europe for improving glycemic control in adults with type 1 diabetes when used in addition to insulin therapy.

FDA approval of Inpefa is based on the results of two placebo-controlled Phase 3 studies, one enrolling type 2 diabetes patients recently hospitalized for worsening heart failure and another that evaluated the drug in patients with type 2 diabetes, chronic kidney disease, and risks for cardiovascular disease. The drug met the goals of both studies. Tolerability of the pill was comparable to a placebo.

Jeffrey Wade, Lexicon’s president and chief financial officer, said Inpefa will benefit from new American Heart Association and American College of Cardiology (ACC) guidelines that recommend SLGT inhibitors as first-line treatments for heart failure. An expert consensus statement recently issued by the ACC specifically stated that SLGT2 inhibitors should be used once patients are stabilized. Wade noted that this status is reflected in Inpefa’s label.

Lexicon expects Inpefa, a once-daily pill, will launch by the end of June. The company is not yet disclosing the drug’s price, but Wade said the wholesale price will be in line with the prices of other heart failure drugs on the market now.

Magicmine, Getty Images

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