Novartis Crizalizumab earns breakthrough designation. The FDA granted its breakthrough therapy designation to Novartis-- crizalizumab. 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% compared to placebos. The drugmaker also reported patients receiving the drug experienced only a 3% incidence of discontinuation due to adverse events. Novartis expects to file an NDA for the drug in the first half of 2019.