FDA pushes orforglipron decision to April 10, Reuters reports
Three other national priority voucher recipients, including Sanofi's Tzield, also had their review timelines extended, according to internal documents Reuters reviewed.
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By Daniel Okafor · Regulatory Correspondent
Jan 15 03:00 ETSource: BioSpace
The wire
- 01Reuters reported the FDA extended its review of Eli Lilly's oral GLP-1 orforglipron, moving the target action date to April 10, 2026, from a previously reported March 28 timeline and an original May 20 deadline.
- 02An oral incretin approval would reshape prescribing and supply planning for clinics and pharmacies now dependent on injectable semaglutide and tirzepatide.
- 03The delay is based on internal documents cited by Reuters rather than an FDA announcement; the agency's Commissioner's National Priority Voucher program promised reviews in one to two months.
From the source
Read at biospace.comFDA Delays Decision for Lilly’s Obesity Pill Orforglipron, Other Priority Voucher Awardees: Report
The FDA has extended its review period for Eli Lilly’s oral obesity drug orforglipron and three other Commissioner’s National Priority Voucher awardees, Reuters reported on Thursday.