The monoclonal antibody Uplizna met key endpoints in a phase 3 trial for the treatment of IgG4-related disease, marking the first time a placebo-controlled study has shown benefit in the condition, according to a press release from Amgen.
Topline results from the double-blind, randomized trial, called MITIGATE, demonstrated an 87% reduced risk for IgG4-related disease (IgG4-RD) flare in patients who received Uplizna (inebilizumab-cdon, Amgen) vs. placebo, and yielded no new safety signals for the drug. The trial also met all key secondary endpoints, including annualized flare rate; flare-free