Keeping Track: US FDA Approval Binge Includes Brexafemme, Wegovy, Ryplazim, Truseltiq, Lybalvi, Tembexa
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Taiho’s Lytgobi Faces Heavy Competition, But Sets Efficacy Bar For Now
The FGFR inhibitor beats prior entrants on efficacy in cholangiocarcinoma, although Relay presented data at ESMO for its investigational RLY-4008 showing especially high efficacy and tolerability.
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.
ESMO: Relay’s RLY-4008 Shows High Response, Lower Toxicity In Cholangiocarcinoma
The new data bolster the company’s hypothesis that more specific targeting of FGFR2 can overcome the toxicity limitations of other FGFR inhibitors.