Eli Lilly’s Strattera wins approval from FDA for ADHD

INDIANAPOLIS The Food and Drug Administration has approved Eli Lilly’s Strattera for the maintenance treatment of attention deficit hyperactivity disorder in children and adults. It is the first non-stimulant to treat ADHD in children, adolescents and adults.

“In the past, our understanding of ADHD treatment was limited to clinical data on short-term use, meaning a few weeks or a couple of months,” said A.J. Allen, Strattera global medical director for Eli Lilly. “For the first time, clinicians have guidance that Strattera is effective for up to a year in patients who respond well to initial treatment.”

The drug was approved after Lilly submitted 18 months worth of clinical trial data which showed that the drug was significantly greater than the placebo in measuring response rates. Also, it had a much bigger impact on reducing relapse rates as compared to the placebo: 2.5 percent for Strattera users compares to 12.2 percent for placebo users.

According to the FDA, Strattera had sales of over $535 million last year.