Fitusiran Delay Dents Sanofi’s Hemophilia Challenge
Company Still Aiming For Universal Therapy
New data show fitusiran’s promise across hemophilia A and B, but a switch to a lower dose prompted by safety concerns will delay its filing until 2024.
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Sanofi’s decision is influenced by its own in-house options, but also by the growing competition in sickle cell gene therapy.
The therapy could also face competition from players like Freeline, but new Phase III data position uniQure and CSL Behring well for planned FDA and EMA filings.
The French major stressed to Scrip that patients enrolled in its fitusiran clinical trials often have other health issues and various co-morbidities, so it is too early to know if the adverse events are treatment-related.