FDA grants orphan drug status to ZW25 for Gastric Cancer Treatment
US Food and Drug Administration has awarded orphan drug designation to Zymework’s leading product candidate.
Release Date: 24-Mar-2017
US Food and Drug Administration has awarded orphan drug designation to Zymework’s leading product candidate, ZW25 for the treatment of gastric cancer and cancer of the gastroesophageal junction (GEJ). Presently, the dug is being examined under Phase 1 clinical trial in patients with advanced HER2 expressing cancers.
ZW25 is a bio assisted antibody formulated to tie up with two non-overlapping epitopes of HER2 resulting in dual HER2 signal blockade, followed by its removal from cell surface and enhanced effector function.
FDA grants orphan drug designation to those products like drugs and therapies that treat rare diseases. The administration defines rare diseases as those affecting fewer than 200,000 people in United States. Orphan drug designation provides certain financial benefits such as incentives to the developing company. These benefits include market exclusivity for the marketing application, if regulatory approval is received for the designated indication, potential tax credits for certain activities and waiver of certain administrative fees.
“Global Orphan Drug Clinical Pipeline Insight” reports by kuick research gives comprehensive insight on various clinical and non-clinical aspects associated with ongoing clinical trials of 808 orphan designated drugs across the globe. The in-depth clinical insight presented in the report helps the reader to analyze and identify the various stakeholders involved in the clinical development and commercialization of orphan designated drugs in the global market. Currently there are more than 300 orphan designated drugs commercially available in the global market and around 800 drugs in clinical development phase.
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