Eli Lilly is celebrating the news that US regulators have granted expanded approval to its attention-deficit hyperactivity disorder drug Strattera.

The US Food and Drug Administration has approved Strattera (atomoxetine) for maintenance treatment of ADHD in children and adolescents. This means that the drug, a selective norepinephrine reuptake inhibitor, is the first FDA-approved non-stimulant to treat the disorder in children, adolescents and adults.

The new approval was based on an 18-month trial involving 604 youngsters aged between six and 15 who met criteria for ADHD. The results demonstrated that Strattera was superior to placebo in maintaining continuous efficacy in patients and had lower relapse rates (2.5% versus 12.2%.

AJ Allen, Strattera global medical director, said that 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". Now, "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 expanded approval will help Lilly take on the two stimulants that dominate the ADHD market, namely Shire’s Adderall XR (mixed amphetamine salts) and Novartis' Ritalin (methylphenidate). Since its first approval in the USA in 2002, more than five million patients have taken Strattera worldwide and it is a big earner for Lilly, bringing in $148 million in the first quarter, up 6%, though they fell 2% in the USA due to a decline in demand.