STOCKHOLM, Sweden The Food and Drug Administration has approved Diamyd Medical to include American children with Type 1 diabetes as young as 10 years old to participate in the company’s phase-three study for the diabetes vaccine Diamyd.
The aim of the study is to determine the ability of the Diamyd vaccine to stop or slow the autoimmune attack on the body’s insulin producing cells, therefore preserving the body’s own ability to produce insulin in children and adolescents with recent-onset Type 1 diabetes.
Prior to FDA authorization, diabetic children ages 16 to 20 years were the only approved age group for Diamyd Medical’s U.S. study. The problem is that this age group encompasses few recent-onset Type 1 diabetes patients.
“This is a big step forward giving us the opportunity to accelerate patient recruitment in the U.S.,” said Elisabeth Lindner, president and CEO of Diamyd Medical.
As the Institutional Review Board authorizes patients in the United States, Diamyd will also increase the number of American pediatric clinics in the study. The application for market approval is still planned for spring 2011.