www.fdanews.com/articles/198078-boehringer-ingelheims-ofev-grabs-european-approval-for-pulmonary-fibrosis
Boehringer Ingelheim’s Ofev Grabs European Approval for Pulmonary Fibrosis
July 16, 2020
The European Commission has approved Boehringer Ingelheim’s Ofev (nintendanib) for treatment of patients with chronic fibrosing interstitial lung diseases (ILD) with a progressive trait.
The approval was based on a phase 3 trial in which the treatment reduced the risk of death or acute exacerbations compared to a placebo. It also slowed lung function decline by 57 percent.
The FDA approved Ofev as the first treatment for the same patient population in March.