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The agency cited immunogenicity concerns, saying there was limited data on the quality, stability and consistency of the compounds

The trial reached its primary end point, demonstrating a significantly lower annual rate of decline of FVC in the patients treated with nintedanib: 80.8 ml per year for the treatment arm compared to 187.8 ml per year for the placebo arm ( p 70%) as the serum level of IL-6 is correlated with the progression of SSc-ILD (65) as well as with increased decline in FVC and increased mortality (66)

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch