Kamada’s KamRAB Meets Primary Endpoint

Eyeing U.S. approval, Israeli drugmaker Kamada says its therapy to treat patients exposed to rabies demonstrated positive results in a pivotal Phase 2/3 study.

The study of KamRAB — which is marketed in 10 countries — met its primary endpoint of noninferiority versus a reference product, the company says. Kamada has a strategic agreement with Kedrion on clinical development and marketing of the product in the U.S.

The company says a BLA filing for the candidate, which will be known as KedRAB, is planned for next year.