20 Aug 2016
Zymeworks Inc., a biopharmaceutical company discovering and developing innovative multi-functional protein-based therapeutics, including bi-specific antibodies and drug conjugates for the treatment of cancer, announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug designation to Zymeworks’ lead investigational products ZW25 and ZW33 for the treatment of ovarian cancer.
Orphan drug designation qualifies Zymeworks for a number of development incentives including tax credits for clinical testing and marketing exclusivity for a period of seven years if ZW25 or ZW33 is approved for this indication.
Each year, more than 22,000 women in the US are diagnosed with ovarian cancer and it is responsible for more than 14,000 deaths. There are currently no HER2-targeted treatments approved for ovarian cancer and poses a significant unmet medical need for patients