October 16, 2014
By Krystle Vermes, BioSpace.com Breaking News Staff
The U.S. Food and Drug Administration announced its approval of Boehringer Ingelheim’s new idiopathic pulmonary fibrosis drug, Ofev, also known as nintedanib, earlier this week. The FDA also granted Ofev fast track, priority review, breakthrough, and orphan product designations.
“[Ofev’s] approval expands the available treatment options for patients with idiopathic pulmonary fibrosis, a serious, chronic condition,” said Mary Parks, deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Providing health care professionals and patients with additional treatment options helps enable appropriate care decisions based on a patient’s need.”
IPF is a disease where the tissue in the lungs become hardened or scarred over time. In turn, the lungs cannot move oxygen efficiently into the blood stream. Organs throughout the body do not receive the oxygen they need to function properly.
Ofev is a kinase inhibitor that blocks pathways thought to be involved in the scarring of lung tissue. Three clinical trials that involved 1,231 patients with IPF were used to determine the effectiveness and safety. Ofev has been shown to improve the decline in forced vital capacity in patients – the amount of air that can be exhaled when taking the deepest breath possible. The most common side effects cited in patients who took the drug were diarrhea, nausea and abdominal pain.
