The FDA’s Arthritis Advisory Committee voted 10-7 in support of nintedanib (Ofev) as a therapy for systemic sclerosis-associated interstitial lung disease (SSc-ILD), according to the agency and manufacturer Boehringer Ingelheim.
Currently marketed to treat idiopathic pulmonary fibrosis (IPF), nintedanib would become the first drug approved for SSc-ILD, a condition with few other options for treatment. SSc-ILD is the leading cause of death in systemic sclerosis, also known as scleroderma, which affects multiple organ systems. About one in four SSc patients develops lung disease within 3 years of diagnosis.
Data submitted by sponsor Boehringer Ingelheim indicated the drug slowed loss of pulmonary function by 44% (41 mL/year) in patients with SSc-ILD relative to placebo, as measured by forced vital capacity (FVC) over a 52-week period.