Boehringer’s TKI inhibitor Ofev gets FDA approval for chronic fibrosing interstitial lung diseases with a progressive phenotype
pharmafile | March 10, 2020 | News story | Manufacturing and Production, Sales and Marketing | Boehringer, FDA, ofev, pharma
The FDA has green-lit Boehringer Ingelheim’s multi-targeted tyrosine kinase inhibitor Ofev (nintedanib) in the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, it has emerged.
The FDA made its judgement on the back of Phase 3 data drawn from the first ILD study to focus on the clinical behaviour of the disease rather than primary clinical diagnosis, and group patients according to these criteria.
The approval comes just six months after the therapy was awarded Breakthrough Therapy Designation from the FDA for chronic fibrosing ILDs with a progressive phenotype, back in October last year.
“Chronic fibrosing ILDs with a progressive phenotype lead to respiratory symptoms and worsening lung function,” said Dr Kevin Flaherty, Professor of Medicine, Division of Pulmonary and Critical Care Medicine at the University of Michigan, and lead investigator of the INBUILD trial. “This approval provides a therapeutic option for many patients who did not have an approved treatment until today.”
ILDs are a group of over 200 rare diseases, and includes conditions like chronic hypersensitivity pneumonitis, sarcoidosis, myositis, sjogren’s syndrome, coal workers pneumoconiosis and idiopathic forms of interstitial pneumonias. These conditions can lead to pulmonary fibrosis which can irreparably affect functioning of the lungs. In around 18-32% of ILD patients, chronic fibrosis will continue to progressively get worse.
Matt Fellows
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