The US Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals' Ofev (nintedanib) capsules to treat idiopathic pulmonary fibrosis (IPF).
Ofev is a kinase inhibitor that blocks multiple pathways that may be involved in the scarring of lung tissue and these capsules will be available to patients within 10 days, the company said.
These twice daily oral capsules have been granted fast track, priority review, orphan product and breakthrough designations by the FDA.
IPF is a condition in which the lungs become progressively scarred over time.This fatal lung disease affects as many as 132,000 people in the US.
Most people with IPF only live three to five years after diagnosis. The disease affects men over the age of 65.
FDA Center for Drug Evaluation and Research’s Office of Drug Evaluation II deputy director Mary Parks said the approval of Ofev expands the available treatment options for patients with idiopathic pulmonary fibrosis, a serious, chronic condition.
"Providing health care professionals and patients with additional treatment options helps enable appropriate care decisions based on a patient’s need," Parks said.
The approval is based on data from one Phase II trial and two Phase III trials, which were randomized, double-blind, placebo-controlled trials comparing Ofev 150mg twice daily to placebo for 52 weeks.
The most common side effects of Ofev observed in the trials are diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, decreased weight, and high blood pressure.
Boehringer Ingelheim Clinical Development and Medical Affairs pulmonologist and senior vice president Tunde Otulana said the approval is a major milestone in IPF with OFEV showing a significant impact on the slowing of lung function decline and a significant reduction in the risk of a first acute exacerbation of IPF over 52 weeks.
"As a research-driven pharmaceutical company, moments like these, when we can bring a treatment option to patients who are very much in need, makes us extremely proud and inspires us to continue our quest for effective therapies to positively impact patients’ lives," Otulana said.
Image: Boehringer Ingelheim’s corporate headquarters in Ingelheim, Germany. Photo: courtesyofBoehringerIngelheim GmbH.