FDA grants Priority Review for New Drug Application for Nefecon, a down regulator of IgA1, for treatment of IgA nephropathy (IgAN)

Submission is based on positive data from Part A of NefIgArd phase 3 study, which met primary objective of a statistically significant reduction in proteinuria after 9 months of treatment with 16mg dose vs. placebo (31% vs.5% decrease from baseline, respectively, p=0.0005).

Source:

Biospace Inc.