- The FDA approved Sanofi SA’s (NASDAQ:SNY) Altuviiio, previously referred to as efanesoctocog alfa, a first-in-class, high-sustained factor VIII replacement therapy.
- Altuviiio is indicated for routine prophylaxis, on-demand treatment to control bleeding episodes, and perioperative management (surgery) for adults and children with hemophilia A.
- Sanofi says Altuviiio is the first and only hemophilia A treatment that delivers normal to near-normal factor activity levels (over 40%) for most of the week with once-weekly dosing and significantly reduces bleeds compared to prior factor VIII prophylaxis.
- Regulatory submission in the EU is anticipated in the second half of 2023.
- The FDA approval is based on pivotal XTEND-1 Phase 3 study data. Once-weekly Altuviiio prophylaxis met the primary endpoint, providing significant bleed protection with a mean annualized bleeding rate (ABR) of 0.70 and a median of 0.0.
- Altuviiio showed a significant reduction of 77% in ABR versus prior factor prophylaxis based on an intra-patient comparison.
- Additional data showed prevention of joint bleeds with a median annualized joint bleeding rate of 0.
- Additionally, interim data from XTEND-Kids showed that children younger than 12 years receiving once-weekly Altuviiio for 26 weeks (n=23) experienced a mean ABR of 0.5 and a median ABR of 0.
- SNY Price Action: Sanofi shares are down 0.58% at $48.03 during the premarket session on the last check Friday.
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