Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.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.
Subscribe to our email newsletter
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.