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US FDA Continues Shutout Of Companies Seeking Drug Rejection Hearings

 
• By Brenda Sandburg

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.

Strikeout
Lexicon and Intarcia strike out in challenging FDA rejection of their drug applications • Source: Shutterstock

Intarcia Therapeutics, Inc. and Lexicon Pharmaceuticals, Inc. had some hope of convincing the US Food and Drug Administration not to reject their new drug applications when the agency offered them the chance to request a hearing to make their case. But like others before them, they have struck out in their appeals for a hearing.

Both applications shared broad similarities (seeking to enter well-established drug classes for diabetes, though different types) and concerns (safety

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