2023-05-26 09:28:04 ET
A committee of the European Medicines Agency (EMA) recommended revoking the marketing authorization of Novartis' ( NYSE: NVS ) Adakveo, which is used to preventing painful crises (called vaso-occlusive crises) in patients aged 16 years and older with sickle cell disease (SCD).
Adakveo (crizanlizumab) was granted conditional approval in in the EU in October 2020.
The EMA's Committee for Medicinal Products for Human Use (CHMP) said on Friday that the opinion follows a review by the panel, which concluded that the benefits of the drug did not outweigh its risks.
The review looked at results of a phase 3 trial called STAND, showed that Adakveo did not reduce the number of painful crises leading to a healthcare visit. Adakveo had on average 2.5 painful crises with a subsequent healthcare visit over the first year of therapy, compared with 2.3 crises in the placebo group, the agency added.
The CHMP noted that it also looked at data from other studies, a managed access program and real?world data. But, the studies had several limitations, such as the lack of a comparator, and could not be used to show the effect of Adakveo or counterbalance the negative results of the STAND study.
The agency added that the STAND study did not raise new concerns but showed a higher rate of severe and serious treatment-related side effects for Adakveo versus placebo.
The EMA had requested the STAND study as a condition for the marketing authorization of Adakveo, as at the time of conditional approval the data were limited and there was some uncertainty about the size of the medicine's effect, the CHMP noted.
The CHMP said that as the STAND study data do not confirm the benefits previously seen with Adakveo, the panel concluded that the benefits do not outweigh the risks and recommended the revocation of the drug's authorization in the EU.
Following the CHMP's recommendation, the European Commission (EC) will issue a legally binding decision.
SCD is a group of inherited disorders in which the red blood cells become hard and sticky, looking like a sickle, and die early.
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EMA recommends revoking approval of Novartis' sickle cell disease drug Adakveo in EU