FDA approves Nerandomilast (Jascayd) for Idiopathic Pulmonary Fibrosis
The Pulmonary Fibrosis Foundation is pleased to share encouraging news for our community - a groundbreaking new therapy will soon be available for individuals living with idiopathic pulmonary fibrosis (IPF).
It has been more than decade since a new treatment was approved for IPF, a form of interstitial lung disease characterized by scarring in the walls of the air sacs in the lung. The disease severely impacts patients' ability to breathe.
Today, the U.S. Food and Drug Administration approved Boehringer Ingelheim's nerandomilast (Jascayd) for treatment of IPF. Nerandomilast, an oral phosphodiesterase 4B (PDE4B) inhibitor, demonstrated statistically significant efficacy in slowing the rate of lung function decline among participants in the Phase III FIBRONEER-IPF clinical trial. Data from the positive phase 3 FIBRONEER-ILD trial of nerandomilast in progressive pulmonary fibrosis is expected to be reviewed by the FDA in the coming months.
This approval represents an important milestone for patients, caregivers, and clinicians, offering new possibilities in the care and management of pulmonary fibrosis, and helping to close the gap on unmet needs for patients living with IPF. Yet, the burden of this disease remains profound, and the need for additional effective treatments continues.
The Pulmonary Fibrosis Foundation remains steadfast in its commitment to advancing research, expanding education, and providing essential support to patients and their families. Together with our partners across the scientific and patient communities, we will continue working toward improved outcomes and, ultimately, a cure for pulmonary fibrosis.