The following is a press release from Sanofi. Read the press release in its entirety here.
Sanofi will resume fitusiran dosing in ongoing U.S. adolescent and adult clinical studies. Fitusiran is an investigational, small interference RNA therapy in development for the treatment of people with hemophilia A or B, with or without inhibitors. Sanofi鈥檚 first priority is patient safety. The company voluntarily paused dosing in all ongoing fitusiran clinical studies on Oct. 30, 2020 to assess reports of non-fatal thrombotic events in patients participating in the Phase 3 program.
Sanofi promptly completed the assessment of available data and aligned with the U.S. Food and Drug Administration to rapidly resume fitusiran dosing for patients in the 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. Evaluation of dosing in the fitusiran pediatric study is ongoing and therefore, dosing in that study remains paused at this time.
Outside the U.S., Sanofi continues engaging with health authorities to resume fitusiran dosing worldwide, with the protocol amendments, as quickly as possible.
To allow for the appropriate collection and assessment of safety and efficacy data under the amended protocols, the company expects that global regulatory submission timelines for the adult and adolescent studies will be delayed by up to approximately 18 months, subject to alignment with health authorities.
Sanofi is committed to addressing the unmet needs of the global hemophilia community through scientific innovation. The company continues to believe fitusiran has the potential to transform treatment for people with hemophilia A or B, with or without inhibitors.
Read the press release in its entirety here.聽