Keeping Track: Zegalogue Joins Hypoglycemia Space; Keytruda Earns First-Line Esophageal Cancer Claim
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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Citing changing therapeutic landscape and doubts about utility of checkpoint inhibitor monotherapy in this setting, advisory committee votes 6-2 against maintaining PD-1 inhibitor’s accelerated approval for third-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma.
Novo Nordisk’s semaglutide, a GLP-1 agonist marketed in an injected formulation as Ozempic, and an oral tablet form as Rybelsus, is a success story with the potential for an epic third act. First approved as a treatment for type 2 diabetes, semaglutide is under FDA review as a treatment for obesity, with additional clinical programs in NASH and Alzheimer’s disease.
Despite being third to market behind Lilly’s Baqsimi and Xeris’s Gvoke to treat emergency episodes of hypoglycemia, Zealand is confident of a successful US launch for Zegalogue (dasiglucagon).