Sanofi and Sobi Score US Approval for Weekly Hemophilia A Therapeutic

Altuviiio, Sanofi and Sobi’s therapeutic for the blood disease hemophilia A, has just received regulator approval by the US Food and Drug Administration (FDA). The drug stands out in its class due to its dosage regimen; the therapy is delivered once a week versus every couple days with the current standard of care.

According to Emily Kimber, “Once-weekly Altuviiio prophylaxis met the study’s primary endpoint, providing significant bleed protection for people with severe haemophilia A with a mean annualised bleeding rate (ABR) of 0.7 and a median ABR of zero. The treatment also met the key secondary endpoint of the study, with a significant reduction of 77% in ABR versus prior factor prophylaxis based on an intra-patient comparison.”

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(Source: PM Live, February 24^th, 2023)