Boehringer Ingelheim Prepares NDA Filing for Pulmonary Fibrosis Drug After Positive Phase 3 Results

Boehringer Ingelheim's Phase 3 Trial Success:
The company has announced positive topline data from a Phase 3 trial investigating nerandomilast in idiopathic pulmonary fibrosis (IPF), paving the way for a New Drug Application (NDA) filing.

Nerandomilast's Potential:
Nerandomilast is a new compound being developed by Boehringer Ingelheim for the treatment of IPF, a chronic and progressive lung disease characterized by scarring of lung tissue.

Background on Nintedanib:
Boehringer Ingelheim's existing drug, nintedanib (Ofev), was approved for the treatment of IPF in 2014 and later for systemic sclerosis-associated interstitial lung disease (SSc-ILD) in 2019.

Continued Research:
The company is also conducting trials with another compound, BI 1015550, in patients with IPF and progressive fibrotic interstitial lung disease (PF-ILD), exploring its potential as an add-on therapy to existing antifibrotics.

Future Directions:
The success of nerandomilast in Phase 3 trials and the ongoing research with BI 1015550 underscore Boehringer Ingelheim's commitment to developing treatments for pulmonary fibrosis and related conditions.