GRI Bio (NASDAQ: GRI) has announced that the FDA has granted Orphan Drug Designation (ODD) to GRI-0621 for the treatment of idiopathic pulmonary fibrosis (IPF), a progressive, irreversible and ultimately fatal lung disease affecting tens of thousands of patients in the U.S.
According to GRI, the designation provides a potential pathway to seven years of U.S. market exclusivity.
In a statement, Marc Hertz, PhD, CEO of GRI commented, “Receiving FDA ODD for GRI-0621 in IPF is an important validation of our development strategy and highlights the urgent need for innovative therapies capable of altering the course of this devastating disease. We believe GRI-0621’s differentiated mechanism of action has the potential to address key drivers of inflammation and fibrosis, and this designation strengthens our ability to advance the program efficiently while creating significant long-term value for patients and shareholders.”
