The recommendation was based on the SENSCIS trial results, orginally shared at ATS 2019 this year.
The US Food and Drug Administration (FDA) Arthritis Advisory Committee has recommended for the approval of nintedanib (Ofev) for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD).
The advisory committee voted 10-7 in favor of the Boehringer Ingelheim therapy’s application to become the first drug marketed for patients with SSc-ILD in the US on Thursday. Their recommendation was based on the findings of the phase 3 Safety and Efficacy of Nintedanib in Systemic Sclerosis (SENSCIS) trial.
The trial results—previously published in the New England Journal of Medicine and presented at the American Thoracic Society (ATS) 2019 International Conference in Dallas, TX—showed patients administered the antifibrotic and anti-inflammatory drug had reduced regression in annual forced vital capacity (FVC) versus patients given placebo.
That said, investigators also found that nintedanib’s clinical benefits were solely reserved for ILD patients with associated systemic sclerosis—better known as scleroderma. ILD is the leading cause of early deaths among patients with scleroderma, and is common among the 25% of patients who develop a significant pulmonary involvement within 3 years of diagnosis.
In an interview with MD Magazine® at ATS 2019, SENSCIS investigator Kristin Highland B. MD, director of the Rheumatic Lung Disease Program at the Cleveland Clinic, explained how the study’s primary outcome assessment of FVC loss reduction over 1 year is a viable metric for improved care in patients with SSc-ILD.
“Sometimes it's obvious when they have extensive skin involvement, but sometimes the extra pulmonary manifestations can be more subtle,” Highland explained. “And so, treatment strategies for scleroderma interstitial lung disease are different than for idiopathic pulmonary fibrosis. So forced vital capacity is really our best surrogate for overall lung function and it does track with what we see on chest CT; it does track with survival.”
The supplemental New Drug Application (sNDA) submitted to the FDA in the first quarter of 2019 was eventually granted Priority Review; the FDA will formally decide on the marketing application of nintedanib later this year.