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FDA Approves Ofev (Nintedanib) for Treatment of Idiopathic Pulmonary Fibrosis
The FDA has approved Ofev (nintedanib, Boehringer Ingelheim) for the treatment of idiopathic pulmonary fibrosis (IPF).
In IPF, the lungs become progressively scarred over time. As a result, patients with the disease experience shortness of breath and cough, and have difficulty participating in everyday physical activities. Current treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplant.
The FDA, which had granted nintedanib “fast track,” “priority review,” “orphan product,” and “breakthrough therapy” designations, approved the drug ahead of the prescription drug user fee goal date of January 2, 2015.
Nintedanib is a kinase inhibitor that blocks multiple pathways that may be involved in the scarring of lung tissue. Its safety and effectiveness were established in three randomized, double-blind, placebo-controlled clinical trials involving 1,231 patients with IPF. These studies assessed the forced vital capacity (FVC) — the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible — in patients receiving nintedanib 150 mg twice daily compared with patients receiving placebo.
All three trials — the phase II TOMORROW study and the phase III INPULSIS-1 and INPULSIS-2 studies — demonstrated a consistent, statistically significant reduction in the annual rate of decline in FVC with nintedanib compared with placebo. The relative reductions were in FVC were 68% in TOMORROW, 52% in INPULSIS-1, and 45% in INPULSIS-2.
In addition, the time to the first acute IPF exacerbation was significantly reduced in patients receiving nintedanib compared with those given placebo in TOMORROW and INPULSIS-2 (but not in INPULSIS-1, which found no difference between the treatment groups).
The most common side effects of treatment included diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, decreased weight, and high blood pressure.
Nintedanib is not recommended for patients with moderate-to-severe liver problems, and treatment can cause birth defects or death to an unborn baby.
The FDA approved Esbriet (pirfenidone, InterMune) for the treatment of IPF on the same day that it approved Ofev.