The US FDA has cleared Eisai's ACIPHEX Sprinkle (rabeprazole sodium) as 12-week gastroesophageal reflux disease (GERD) therapy for use in children between one to eleven years age.
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.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-clears-eisai-gastroesophageal-reflux-disease-therapy-for-children-280313
