The European Commission (EC) has officially adopted a decision that aligns with the Committee for Medicinal Products for Human Use (CHMP) recommendation. This decision pertains to revoking the conditional marketing authorization (MA) for Adakveo (crizanlizumab), an approved treatment.
On May 26, 2023, the CHMP advised revoking the conditional MA for crizanlizumab. Subsequently, on August 3, 2023, the European Commission endorsed the CHMP's recommendation. Given the European Commission's decision, Novartis, the pharmaceutical company behind crizanlizumab, will withdraw the product from the EU market.
The review was prompted by the outcomes of the phase III study known as STAND (NCT03814746). The results from the STAND study indicated that there was no statistically significant disparity between crizanlizumab 5mg/kg, crizanlizumab 7.5mg/kg, and placebo regarding the annualized rates of vaso-occlusive crises necessitating healthcare visits during the first year post-randomization.
Notably, the STAND study did not highlight any fresh safety concerns associated with crizanlizumab. However, the drug is still approved by the US FDA for reducing the frequency of vaso-occlusive crises in sickle-cell patients. Novartis announced that it is engaging in discussions with the US FDA and other global health authorities to further address and evaluate the findings from the STAND study.
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.