FDA (Image: AP)
FDA to Lexicon: Yeah, that's still gonna be a no from us
Lexicon’s last hopes for a quick resurrection of its Type 1 diabetes drug in the US have been quashed.
The Texas-based biotech announced that the FDA’s Office of New Drugs has declined its appeal of the complete response letter from the agency rejecting their SGLT1/2 drug. The second rejection is the latest bump in a long, rough slide for a company whose drug sotagliflozin once garnered $300 million upfront and $1.4 billion in potential milestones to be Sanofi’s new prospective diabetes blockbuster.
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