CercleFinance.com) - Sanofi announces that the US FDA Advisory Committee has made a statement regarding the approval of Zynquista (sotagliflozin), with voting equally split (eight-to-eight), with indecision as to whether the drug's overall benefits outweigh risks.
Developed by Sanofi and Lexicon, Sotaglifozin is subject to a regulatory study for oral administration, in addition to insulin, for the treatment of type-1 diabetes in adults.
'While the FDA is not required to follow the committee's vote, the agency considers the committee's recommendations when making its decision, which is anticipated by March 22, 2019,' Sanofi said.