FDA OKs new use of Boehringer Ingelheim’s Ofev

Under Priority Review and Breakthrough Therapy status, the FDA approves privately held Boehringer Ingelheim’s Ofev (nintedanib) oral capsules for the treatment of patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait).

Data from a pivotal study in a range of these patients showed that treatment with the kinase inhibitor slowed the rate of pulmonary function loss by 57% compared to placebo.

The FDA first approved Ofev in October 2014 for ideopathic pulmonary fibrosis followed by a second nod in September 2019 for ILD associated with systemic sclerosis or scleroderma.

ILD-related tickers: Roche (OTCQX:RHHBY -5.3%), United Therapeutics (UTHR -5.5%), aTyr Pharma (LIFE -10.2%), Bellerophon Therapeutics (BLPH -12.8%)

https://seekingalpha.com/news/3549868-fda-oks-new-use-of-boehringer-ingelheims-ofev