FDA Approves Boehringer Ingelheim's Ofev For IPF

The Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s Ofev (nintedanib) for idiopathic pulmonary fibrosis (IPF). The approval was announced in a press release, and the company also stated that the medication will be available within 10 days. The FDA had previously granted nintedanib Breakthrough Therapy designation for the treatment of the fatal lung disease. This announcement came the same day that the FDA granted approval to another IPF treatment (InterMune’s Esbriet) — a huge deal for the industry considering there had yet to be any approved treatments for IPF. The European Medicines Agency (EMA) is currently reviewing the treatment.

Ganesh Raghu, M.D., Professor at the University of Washington in Seattle, said, “While the cause of IPF is unknown and there is no known curative treatment, the unfortunate patients confronted with the disease and physicians caring for patients in the U.S. have been anxiously awaiting FDA-approved treatments.”

Ofev

Ofev (nintedanib) is a tyrosine kinase inhibitor (TKI), a capsule taken twice daily. The agent slows lung function decline with an understood action mechanism. It inhibits platelet-derived growth factor receptors (PDGFRs), fibroblast growth factor receptors (FGFRs), and vascular endothelial growth factor receptors (VEGFRs). Clinical trials of nintedanib showed a 50 percent reduction in annual decline in lung function. In two identically-designed Phase 3 clinical trials, nintedanib reduced the risk of acute exacerbations, which often cause hospitalizations and mortality.

The FDA based its approval on a Phase 2 trial (TOMORROW) and two Phase 3 trials (INPULSIS-1, and INPULSIS-2). The TOMORROW trial was a 12-month study with a placebo. The 432 patients in 25 countries took one of four doses of nintedanib. The 150 mg dose resulted in a forced vital capacity (FVC) score of 0.06 liters per year compared to 0.19 liters in the placebo patients. The dose also lowered exacerbations and improved the patient’s quality of life.

The INPULSIS trials were placebo controlled and involved 1,066 patients in 24 countries. Patients took 150 mg of nintedanib twice daily over 52 weeks. Results showed that patients experienced a 50 percent decline in FCV compared to placebo patients and a reduction in exacerbations. A common side effect in the three trials was gastrointestinal discomfort from mild to moderate intensity, however it rarely led to treatment discontinuation.