Drug Rejection Hearings Are Having A Moment At US FDA
With Intarcia's request, the rarely used mechanism could now produce two hearings this year, but outcomes of the few other times the process has been undertaken should not generate a lot of confidence for sponsors that this a path that they want to go down.
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Intarcia, CDER Tussle Over Advisory Cmte. Process For Hearing On Denial Of Diabetes Combo Product
Seeking to reverse CDER’s proposal to reject the NDA, Intarcia wants a say in formulating issues to be presented to the committee and questions inclusion of device experts as ad hoc members that will consider the fate of ITCA 650, a subdermal pump which delivers the GLP-1 agonist exenatide.
Device Component Of Intarcia’s Diabetes Treatment ITCA 650 Worries FDA
If FDA chief scientist grants Intarcia’s request for advisory committee meeting, CDER wants to provide input on issues to be considered. Director Cavazzoni says the novel drug-device combination product does not notify the user of a critical failure or infusion status.
US FDA Continues Shutout Of Companies Seeking Drug Rejection Hearings
Intarcia and Lexicon fail to convince FDA's Center for Drug Evaluation and Research to grant hearings after complete response letters. Intarcia contends that kidney injury with its diabetes drug implant is similar to Novo Nordisk’s Wegovy, while Lexicon argues that CDER did not adequately consider a REMS when reviewing its SGLT2 inhibitor.