study showed that the mean dose that can be withdrawn from a vial is 11 mg. Therefore, basedon the dose recovery study, the mean dose delivered in the trial was 11 mg.

The efficacy of CABLIVI in patients with aTTP was established based on time to platelet countresponse (platelet count ≥150,000/µL followed by cessation of daily plasma exchange within 5

days). Time to platelet count response was shorter among patients treated with CABLIVI,compared to placebo. 

Figure 1: Platelet Response over Time

Treatment with CABLIVI resulted in a lower number of patients with TTP-related death,recurrence of TTP, or at least one treatment-emergent major thromboembolic event (a composite

endpoint) during the treatment period (see Table 2).

Table 2: Patients in the HERCULES Study with aTTP-Related Death, a Recurrence ofaTTP, or at Least One Treatment-Emergent Major Thromboembolic Event During StudyDrug Treatment Period (ITT population)

CABLIVI

N=72

Placebo

N=73

Number of patients with n (%)* n (%)

TTP-related death 0 3 (4.1)

Recurrence of TTP (exacerbation)†

 3 (4.2) 28 (38.4)

At least one treatment-emergent

major thromboembolic event 6 (8.5) 6 (8.2)

Total‡ 9 (12.7) 36 (49.3)

N = number of patients within the population of interest (by treatment group); n = number of patients with events;

TTP = thrombotic thrombocytopenic purpura; ITT = intent to treat; * based on 71 patients who received at least onedose of study drug.

† Exacerbation defined as thrombocytopenia after initial recovery of platelet count (platelet count ≥150,000/µL

with subsequent stop of daily plasma exchange within 5 days) that required reinitiation of daily plasma exchange  their healthcare provider immediately if excessive

bleeding or bruising occur.

Advise patients to inform their healthcare provider before scheduling any electivesurgery, dental procedure or other invasive interventions.

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