Submit Interim Safety, Efficacy Data: CDSCO Panel Tells Novartis on Crizanlizumab
New Delhi: Reviewing the status of the ongoing studies of Crizanlizumab concentrate for solution for infusion 10mg/mL (100mg/10mL), the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Novartis to submit interim safety and efficacy data of ongoing Phase IV study in India along with periodic safety update report (PSUR) data in Indian population immediately to the authority. This came after the drug major Novartis presented the status of the ongoing studies with the product Crizanlizumab concentrate for solution for infusion 10mg/mL (100mg/10mL), in light of regulatory action by European Medicines Agency (EMA) on marketing authorization (MA) of the product Crinzalizumab(Adakveo), Crizanlizumab is a monoclonal antibody that targets selectin to reduce the frequency of vasooclusive crises in patients with sickle cell disease. Crizanlizumab is a humanized IgG2 monoclonal antibody used to reduce the frequenc...