Ablynx, a Sanofi company, has received FDA approval for its Cablivi (caplacizumab-yhdp) injection in combination with plasma exchange and immunosuppressive therapy for the treatment of adult patients with acquired thrombotic hrombocytopenic purpura. Cablivi was studied in a clinical trial of 145 patients who were randomized to receive either Cablivi or a placebo. Patients in both groups received the current standard of care of plasma exchange and immunosuppressive therapy.
The results of the trial demonstrated that platelet counts improved faster among patients treated with Cablivi, compared to placebo. Treatment with Cablivi also resulted in a lower total number of patients with either aTTP-related death and recurrence of aTTP during the treatment period, or at least one treatment-emergent major thrombotic event.