FDA Approves New Indication for Boehringer Ingelheim’s Lung Disease Drug

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The agency has approved Boehringer Ingelheim’s Ofev (nintedanib), its lung disease drug, for the treatment of patients with systemic sclerosis associated with lung disease.

Boehringer Ingelheim announced on Sept. 9, 2019 that FDA has approved the use Ofev (nintedanib), it’s lung-disease drug, to slow the rate of decline in pulmonary function in patients with systemic sclerosis associated interstitial lung disease (SSc-ILD). Ofev is already approved in the United States and more than 70 countries for treating idiopathic pulmonary fibrosis (IPF). It has been shown to slow IPF progression by reducing the annual rate of decline in lung function, as measured by forced vital capacity (FVC).

The approval was based on results of a Phase III study, the results of which demonstrated that Ofev slowed the loss of pulmonary function by 44% (41 mL/year) in patients with SSc-ILD relative to placebo, as measured by FVC over 52 weeks.

“This is the first FDA-approved therapy to slow the rate of decline in pulmonary function for systemic sclerosis associated interstitial lung disease and provides hope to patients and their loved ones facing this devastating disease,” said Thomas Seck, MD, senior vice-president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, in a company press release. “This approval is supported by positive evidence from the Phase III study that showed Ofev significantly slowed the progression of lung function decline in this patient population and exemplifies Boehringer Ingelheim’s dedication to the rare disease community.”


“An approved anti-fibrotic medication for this condition is a major scientific advancement in the care of patients living with this rare disease,” said Kristin Highland, MD, pulmonlogist with the Cleveland Clinic, in the press release. “The option to offer a new therapy is welcome news for doctors and their patients.”

Source: Boehringer Ingelheim