The approval was based on positive data from multicenter, double-blind trial conducted in 127 pediatric patients between one to 11 years of age with GERD.
Eisai president and CEO Lonnel Coats said, "We are proud to offer a new treatment option for young children who suffer from GERD."
The parallel-group study comprised a treatment period of 12 weeks and an extension period of two dose levels of rabeprazole for 24 weeks.
Healing was achieved in 81% of patients during the treatment period and 90% retained healing during the extension period.