Boehringer’s Pulmonary Fibrosis Drug Gets Fast Track for Systemic Sclerosis Indication

The FDA granted fast track status to Boehringer Ingelheim’s OFEV (nintedanib) for systemic sclerosis.

The agency based the designation on a 520-patient pivotal trial that showed favorable safety and efficacy data.

The drug is already approved for rare lung disease idiopathic pulmonary fibrosis and has slowed disease progression as measured by annual decline rate in lung function. The company evaluated its impact on systemic sclerosis with associated interstitial lung disease because of similarities in how lung scarring forms in both diseases.