Sanofi Has One Hemophilia Winner On It Hands – But Fitusiran’s Fate Remains Unclear
Efanesoctocog Alfa Filed Last Month
Sanofi is hoping to have two paradigm-changing hemophilia drugs on the market by 2025 – but one of these, fitusiran, must first prove its safety and efficacy at a lower dose.
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Sanofi can now expect an FDA decision in early 2023 on efanesoctocog, setting it up for a battle with Roche’s Hemlibra and BioMarin’s gene therapy Roctavian, which was just approved in the EU.
The company announced a respectable increase in second quarter sales and expects to announce topline results within the next three weeks for the Phase III trial of Onpattro in ATTR-CM.
Hemlibra receives new approval in Japan intractable disease indication, while positive Phase III results in mild/moderate disease hemophilia A will support a planned EU filing in this setting.