FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Novartis’ Crizalizumab Earns Breakthrough Designation

Jan. 16, 2019

The FDA granted its breakthrough therapy designation to Novartis’ crizalizumab, the drugmaker announced.

The agency based its designation on positive results for a Phase 2 trial that found the drug reduced the median annual rate of vaso-occlusive crises  in patients of all genotypes with sickle cell disease, which cut healthcare visits by 45.3 percent compared to placebos.

The drugmaker also reported patients receiving the drug experienced only a three percent incidence of discontinuation due to adverse events. Novartis expects to file an NDA for the drug in the first half of 2019.

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