TUESDAY, March 10, 2020 — Ofev (nintedanib) oral capsules have received the first approval for the treatment of patients with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, the U.S. Food and Drug Administration announced Monday.
Ofev, a multitargeted tyrosine kinase inhibitor, was approved in 2014 to treat idiopathic pulmonary fibrosis and to slow pulmonary function decline among patients with ILD associated with systemic sclerosis or scleroderma.
Approval was based on data from the INBUILD trial, a Phase III randomized, double-blind, placebo-controlled study of 663 adults with chronic fibrosing ILD with a progressive phenotype. Patients were aged a mean of 66 years and received 150 mg of Ofev twice a day or placebo. After 52 weeks, lung function decline was slowed by 57 percent relative to placebo in those who received Ofev as measured by forced vital capacity.
The most commonly reported side effects of Ofev included diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, and weight loss. Ofev is contraindicated in patients with moderate or severe hepatic impairment. There have been reports of elevated liver enzymes and drug-induced liver injury and gastrointestinal disorders in people taking Ofev. The drug may also cause embryo-fetal toxicity, arterial thromboembolic events, bleeding, and gastrointestinal perforation. Patients taking P-glycoprotein and CYP3A4 inhibitor drugs, including ketoconazole and erythromycin, should be closely monitored when also taking Ofev because these drugs can increase nintedanib exposure.
Approval of Ofev for the current indication was granted to Boehringer Ingelheim Pharmaceuticals.
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Posted: March 2020