The approval is the third for the Boehringer Ingelheim-produced therapy and the first from the FDA for treating patients with chronic fibrosing interstitial lung diseases with a progressive phenotype.
In a move that will come as a relief to patients and clinicians alike, the US Food and Drug Administration has announced nintedanib (Ofev) oral capsules have received approval for the treatment for people with chronic fibrosing interstitial lung diseases (ILD) with a progressive phenotype.
The FDA announced the approval, which is the first for this specific indication and third for nintedanib, is based on the results of randomized, double-blind, placebo-controlled clinical trial that evaluated 150 mg twice-daily nintedanib’s safety and effectiveness for treating fibrosing lung diseases than worsen over time in more than 650 patients, according to a statement.
“The FDA continues to encourage the development of therapies for patients with limited or no treatment options,” said Banu Karimi-Shah, MD, acting deputy director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, in the aforementioned statement. “Today’s approval helps to fulfill an unmet treatment need, as patients with these life-threatening lung diseases have not had an approved medication until now.”
Nintedanib, a multi-targeted tyrosine kinase inhibitor that inhibits key pathways involved in lung fibrosis in ILDs, demonstrated the ability to slow lung function decline by 57% relative to placebo during the phase 3 INBUILD trial. Boehringer Ingelheim, which produces listed a number of ILDs including autoimmune diseases, chronic hypersensitivity pneumonitis, sarcoidosis, myositis, Sjogren’s syndrome, coal workers pneumoconiosis and idiopathic forms of interstitial pneumonias can cause the type of scarring that nintedanib can now be used to treat.
Safety information from the FDA states the therapy was associated with a number of adverse reactions. Adverse reactions included diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, weight decrease, headache, hypertension, upper respiratory tract infection, nasopharyngitis, upper respiratory tract infection, urinary tract infections, fatigue, and back pain.
"Chronic fibrosing ILDs with a progressive phenotype lead to respiratory symptoms and worsening lung function," said Kevin Flaherty, M.D., professor of medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan in Ann Arbor, Michigan, and lead investigator of the INBUILD trial, in a statement. "This approval provides a therapeutic option for many patients who did not have an approved treatment until today."