ADAKVEO (crizanlizumab): Phase III study (CSEG101A2301) shows no superiority of crizanlizumab over placebo.

Summary:

• Preliminary results from the phase III study CSEG101A2301 (STAND) did not show a difference between crizanlizumab and placebo in annualized rates of vaso-occlusive crises leading to a healthcare visit over the first-year post randomization.
• The preliminary results do not suggest new safety concerns with crizanlizumab. However, higher rates for grade ≥3 treatment-related adverse events were reported for crizanlizumab compared to placebo.
• Further evaluation of the data from study CSEG101A2301 and their potential impact on the benefit-risk balance of crizanlizumab is currently ongoing by EMA. The final conclusions and recommendations will be communicated as soon as the evaluation has been completed.
• While this evaluation is ongoing, physicians should consider the individual benefit and risks when making therapeutic decisions regarding the use of crizanlizumab.