Support for Ofev® just keeps coming!
Ofev® (nintedanib) was first approved by the U.S. FDA in 2014 for the treatment of idiopathic pulmonary fibrosis (IPF) after clinical trials, especially the INPULSIS trial involving 1,066 patients, proved positive results.
Throughout these trials, it was observed that Ofev® reduced the rate of decline in lung function and reduced the rates of adjudicated acute exacerbations in patients suffering from IPF.
Ofev® works by inhibiting the enzyme essential for signal transduction pathways to grow; these growth factors are secreted in excess amounts in people who have IPF, causing scar tissue to form in the lungs. Overall, the inhibition caused by Ofev® slows the progression of IPF.
After Ofev® was approved and was considered to have a well-established safety and effectiveness profile, Boehringer Ingelheim (the drug’s manufacturer) needed to determine the drug’s long-term risks and effectiveness. Since the 2014 FDA approval, data from some previous trials suggested that the drug could slow the progression of IPF for up to 76 weeks and regardless of the initial state of the patient.
However, most recently at the annual American Thoracic Society conference, Boehringer Ingelheim presented data following from the INPULSIS trial that almost 37% of IPF patients who took Ofev® for one year had no decline in “forced vital capacity,” a key measure of lung function. This number was double that of the amount of patients who were on a placebo. Even over a span of 96 weeks, data supported Ofev®’s ability to prevent disease progression over the long term, and without any greater risk of a heart attack.
All of these data provide both physicians and patients with added evidence to use in IPF treatment decisions, and more is on its way as results of the first Phase 4 clinical trial are expected to further solidify Ofev®’s safety.
Dr. Thomas Leonard, the head of Boehringer’s specialty care unit, said,
“through ongoing research, we are able to provide the IPF community with the information they need to make informed treatment decisions.”
For more information about Ofev®, including important safety information, click here.
