Intarcia Gets Chance For AdComm Review Of ITCA 650; Hearing For Sotagliflozin Shot Down
FDA chief scientist encourages Intarcia to request advisory committee review of CDER’s proposal to refuse approval of its drug-device diabetes treatment. CDER again denies Lexicon request for hearing on proposal to deny approval of its SGLT2 inhibitor.
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The Boston biotech raises series A cash and succeeds Intarcia as the sponsor of the GLP-1 drug/device combination product for type 2 diabetes, subject of two FDA complete response letters.
Intarcia Gets Its Hearing: FDA Panel To Weigh Nonapproval Of Diabetes Drug/Device Combo In September
Since the Center for Drug Evaluation and Research is conducting the single-day hearing on the type 2 diabetes treatment ITCA 650 under its usual process for advisory committee meetings, it denied Intarcia’s requests for input on adding ad hoc members and extended presentation time.
Sotagliflozin’s cardiovascular outcomes trials support the most expansive heart failure risk reduction claim approved by the US FDA in the class, a turnaround from the drug’s setbacks in type 1 diabetes.