FDA grants priority review to Roche’s Gazyva/Gazyvaro for pMN

The FDA has granted priority review to Roche’s sBLA for Gazyva/Gazyvaro in the treatment of adults with pMN. The decision is based on results from the Phase III MAJESTY study. pMN is a chronic autoimmune disease that can result in kidney damage and may progress to kidney failure. Credit: sasirin pamai / Shutterstock.com. The US Food and Drug Administration (FDA) has granted priority review to Roche’s supplemental biologics licence application (sBLA) for Gazyva/Gazyvaro (obinutuzumab) to treat adults with primary membranous nephropathy (pMN). The decision is based on results from the Phase III MAJESTY study, which indicated that Gazyva/Gazyvaro achieved a…

Source: Pharmaceutical Technology