Sanofi Genzyme had placed a global dosing hold on its “full clinical development program for fitusiran due to the identification of new adverse events.”
Fitusiran is a once-once monthly, subcutaneously dosed non-factor-replacement therapy. Hmm, that sounds like a controversial product that is already on the market.
Sanofi has indicated that as of October 30, they had “voluntarily paused dosing and enrollment in the ongoing fitusiran clinical studies to allow investigation of reports of non-fatal thrombotic events in patients in the trials. This decision is in alignment with the independent external Data Monitoring Committee.”
We will keep you posted if we hear that the program has restarted.