FDA Approves First Treatment for Chronic Fibrosing ILDs with Progressive Phenotype
The US Food and Drug Administration (FDA) approved Ofev (nintedanib) as the first treatment for people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.
This multi-targeted tyrosine kinase inhibitor is currently approved for idiopathic pulmonary fibrosis (IPF) and to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated ILD (SSc-ILD).
Approval is based on results of the Phase III clinical INBUILD trial, where patients were grouped according to the clinical behavior of their disease as opposed to the primary clinical diagnosis.
Nintedanib received Breakthrough Therapy Designation for chronic fibrosing ILDs with a progressive phenotype in October 2019.
Read the full press release here.