BRIEF—Boehringer progresses nintedanib in new indication

The US Food and Drug Administration has granted Fast Track designation to nintedanib for the treatment of systemic sclerosis with associated interstitial lung disease (SSc-ILD).

Nintedanib, from family-owned German pharma major Boehringer Ingelheim, which is marketed as Ofev, is approved for the rare lung disease idiopathic pulmonary fibrosis, or IPF, and has been shown to slow disease progression as measured by annual rate of decline in lung function.

Because SSC-ILD and IPF share similarities in how the underlying lung scarring, or fibrosis, forms in people with the disease, Boehringer Ingelheim is evaluating the impact of nintedanib on SSC-ILD.

“This Fast Track designation is an encouraging step in our ongoing research and commitment to advancing care of those with systemic sclerosis with interstitial lung disease,” said Christopher Corsico, chief medical officer, Boehringer Ingelheim.

“It is critical that we address the significant unmet medical need of those living with this disease and we are looking forward to working with the FDA to advance the development of this potential therapy,” he added.

Robert Riggs, chief executive of the Scleroderma Foundation, added: “There have been no FDA-approved treatment options for scleroderma with lung involvement and very few drugs assessed in clinical trials for a devastating reality for people living with the disease.”