The U.S. Food and Drug Administration (FDA) has granted approval to Lexicon Pharmaceuticals Inc’s (LXRX.O) drug, sotagliflozin, for the treatment of heart failure. This includes its use in adult patients with type 2 diabetes, according to an announcement made by the company on Friday. The approval has led to a 13% surge in the company’s shares during extended trading, indicating a positive market response.
A Breakthrough for Lexicon Pharmaceuticals
Sotagliflozin, an oral medication, is the first drug developed by Lexicon Pharmaceuticals to receive FDA approval. It will be marketed under the brand name Inpefa. The drug had previously faced setbacks in securing U.S. approval as an add-on therapy to insulin for individuals with type 1 diabetes. However, this recent approval for heart failure treatment marks a significant achievement for the company.
Sotagliflozin’s Mechanism of Action
Sotagliflozin belongs to a class of medicines that help regulate blood glucose levels and mitigate the risk of weight gain by inhibiting SGLT1 and SGLT2 proteins. It acts as a sodium-glucose cotransporter-2 inhibitor (SGLT2 inhibitor) and has demonstrated its efficacy in controlling blood glucose levels in patients with type 2 diabetes.
Similar Drugs on the Market
Another drug, Jardiance, developed by Eli Lilly (LLY.N) and Boehringer Ingelheim, belongs to the same class of medications as sotagliflozin. Jardiance has already received FDA approval for the treatment of heart failure in patients with type 2 diabetes. This class of drugs has shown promise in managing heart failure by reducing cardiovascular risks.
Market Impact and Pricing
Lexicon Pharmaceuticals plans to launch Inpefa by the end of June. The wholesale price of the medication is expected to be comparable to existing branded heart failure medications. Jardiance, being the main competitor, has a current list price of $570.48 for a month’s supply. Analyst Yasmeen Rahimi from Piper Sandler has noted that sotagliflozin presents a unique proposition in heart failure treatment, particularly due to its differentiated benefits in hospitalized patients compared to existing therapies. Rahimi estimates that the drug could generate sales of $112 million by 2025 and approximately $576 million by 2028.
Collaboration and Termination
To develop sotagliflozin, Lexicon Pharmaceuticals partnered with French drugmaker Sanofi SA (SASY.PA). However, Sanofi terminated the collaboration and paid a termination fee of $260 million. Despite this setback, Lexicon Pharmaceuticals continued its efforts and succeeded in obtaining FDA approval for sotagliflozin.
FDA: Clinical Evidence and Efficacy
The FDA approval for sotagliflozin was based on the results of a late-stage study. The study demonstrated that sotagliflozin, when compared with a placebo, reduced the risk of cardiovascular death and hospitalization due to heart failure in adults with type 2 diabetes or certain other underlying health conditions. These positive findings provide strong support for the use of sotagliflozin as an effective treatment option for heart failure in this patient population.
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Promising Future for Heart Failure Treatment
The approval of sotagliflozin marks an important milestone in the management of heart failure, especially in patients with type 2 diabetes. With its unique mechanism of action and proven clinical efficacy, sotagliflozin offers new hope for individuals suffering from heart failure. As Lexicon Pharmaceuticals prepares to launch Inpefa, the company is poised to make a significant impact in the field of cardiovascular medicine.
