Additional Relevant Details
The BLA is based on results announced in December 2015 from a prospective, randomized, double-blind, non-inferiority Phase 2/3 study of 118 healthy subjects. The study evaluated pharmacokinetic (PK) parameters of anti-rabies IgG levels in serum at different time points and assessed whether the human rabies IgG interferes with the development of endogenous antibodies. Study results showed that the primary endpoint of non-inferiority was met with a difference of -1.8 percent between the two therapies with variability between -8.2 percent and 3.1 percent (90 percent confidence limit). No drug-related Serious Adverse Events (SAEs) were experienced by study subjects.Kamada and Kedrion expect a regulatory decision from the FDA on the BLA in mid-2017, and plan on launching the product soon after a favorable decision.