According to Lexicon, Inpefa (sotagliflozin) will continue to be manufactured and made available to patients. The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL ...
In 2022, FDA approved sotagliflozin under the name Inpefa to reduce the risk for cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart ...
Sotagliflozin was approved by the FDA as Inpefa in May 2023 as a once-daily oral tablet that reduces the risk of ...
In 2022, Lexicon achieved success when the FDA approved sotagliflozin under the brand name Inpefa for heart failure, but type 1 diabetes has proven to be a more elusive indication.
The FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted Thursday that it didn't believe the benefits of sotagliflozin ... under the brand name Inpefa. Lexicon is also studying ...