CHMP seeks to pull Adakveo’s conditional approval; drug has full FDA approval

EMA agency issues positive opinions on Pylclari and Ztalmy, label expansions for Opdivo and Sogroya

May 26, 2023 11:14 PM UTC

EMA’s CHMP has recommended revoking the conditional authorization of Novartis’ sickle cell therapy Adakveo, while recommending approval of two new medicines and label extensions for Opdivo and Sogroya.

In January, Novartis AG (SIX:NOVN; NYSE:NVS) reported preliminary data from the ongoing Phase III STAND trial that showed Adakveo crizanlizumab did not differentiate from placebo in annualized rates of vaso-occlusive crises leading to healthcare visits over the first year. The findings were inconsistent with those of the Phase II SUSTAIN trial that formed the basis of the initial conditional approval in 2020...