Sanofi has announced plans to resume dosing in its ongoing fitusiran clinical studies, lifting the voluntary global hold that was initiated on October 30 to assess reports of non-fatal thrombotic events in patients in the phase 3 program.
Sanofi has completed the assessment and aligned with the U.S. Food and Drug Administration to resume fitusiran dosing in the U.S. adolescent and adult clinical studies. “The company will implement amended protocols with an adjusted dose and dosing regimen aimed at further strengthening the benefit-risk profile of fitusiran for patients,” Sanofi said in its announcement on December 10. “Evaluation of dosing in the fitusiran pediatric study is ongoing and therefore, dosing in that study remains paused at this time.”
Sanofi is working with health authorities in other countries to resume fitusiran dosing worldwide, with the protocol amendments. The company expects that adjustments to the new dosing guidelines will delay global regulatory submission timelines for the adult and adolescent studies by up to 18 months.
Sanofi to resume dosing in fitusiran clinical studies in the U.S. (Sanofi, December 10, 2020)
Global dosing hold in fitusiran trials initiated by Sanofi Genzyme to investigate new adverse events (WFH, EHC and NHF Joint Statement, November 6, 2020)