WASHINGTON -- The FDA on Wednesday approved and for treating idiopathic pulmonary fibrosis.
Both drugs were approved on the basis of trial data showing that they slowed the decline in forced vital capacity compared with placebo.
Patients with impaired hepatic function should not take either drug, the FDA said.
Adverse effects associated with nintedanib include fetal abnormalities -- pregnancy is a contraindication -- as well as diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, decreased weight, and high blood pressure.
For pirfenidone, the side effect profile includes photosensitivity, nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, decreased/loss of appetite, gastroesophageal reflux disease, sinusitis, insomnia, decreased weight, and arthralgia. It is also contraindicated in patients with end-stage kidney disease.
Pirfenidone first came before the FDA in 2009, but the agency rejected the application from the drug's manufacturer, InterMune, citing weak efficacy data. The firm then conducted an additional trial that appeared to satisfy the FDA's concerns. Pooled trial data also pointed to a survival benefit, although this apparently did not play a major role in the FDA's decision to approve the drug.
Nintedanib, manufactured by Boehringer Ingelheim, was evaluated in multiple placebo-controlled trials. Results reported earlier this year indicated that the drug cut the rate of decline in forced vital capacity by half compared with placebo.