Novartis Adakveo failed to show benefit over placebo in the Phase 3 trial in SCD patients.
Novartis presented the preliminary results of the Phase 3 study of Adakveo (crizanlizumab), showing no statistical improvement in annualized rates of vaso-occlusive crises (pain crises) versus placebo. Adakveo was tested in two different strengths, 5mg/kg and 7.5mg/kg; both strengths showed no improvement over the placebo.
Novartis announced that these findings are inconsistent with the previously reported SUSTAIN trial in terms of efficacy. The safety profile was consistent with the previous studies.
Novartis further stated that it is working with the regulatory agencies, including EMA, which requested complete data of the STAND study for approval. The US FDA was approved in 2019 for reducing the frequency of vaso-occlusive crises.