Keeping Track: TGT’s Ukoniq Is Latest PI3K Inhibitor To Fall; GSK’s Daprodustat, Aeglea’s Pegzilarginase Headline Submissions
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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US FDA Has History Of Pushing Sponsors On Confirmatory Trials … Sometimes
Even before a new law granted FDA authority to require studies be underway before accelerated approval, review divisions have, in some cases, given sponsors years of advance notice on expectations around study timing, according to a Pink Sheet review of NME accelerated approvals.
A Mixed AdComm: REMS Seems Possible For GSK’s Anemia Drug, Dual Indication Likely Needs More Data
Daprodustat gets a thumbs up from a US FDA advisory committee on one of two proposed indications, but panelists indicate preference for strong pharmacovigilance program for GSK’s oral anemia treatment for chronic kidney disease patients.
FDA Says Safety Concerns May Negate Any Oral Dosing Advantage For GSK’s Anemia Treatment
When a drug’s biggest advantage becomes its potential downfall: The agency worries that chronic kidney disease patients not receiving dialysis may have worse outcomes on GSK’s anemia treatment daprodustat compared to ESA because of less patient safety monitoring as a result of the drug’s oral administration.