The Annual report for Orphan Drug Designation status for SA-033 received no remarks from EMA
Double Bond Pharmaceutical International AB (DBP) has the 20th of September submitted the Annual report for the drug candidate SA-033 to the European Medicines Agency (EMA), which is mandatory after obtaining Orphan Drug Designation status. The Annual report received no remarks or objections, which means that the development of the product is in line with EMA’s requirements and expectations. The company was originally granted Orphan Drug Designation status in June 2015 by EMA for SA-033. The Designation applies to the treatment of hepatoblastoma, which is the most frequent type of liver