FDA Wants More Data on Shire’s ADHD Drug

Shire said Thursday the U.S. Food and Drug Administration sent an approvable letter for Intuniv, an attention-deficit hyperactivity disorder treatment.

The information requested by the FDA was not unexpected, and Shire is working with the FDA to provide a full and timely response to the agency’s request, the company said in a statement.

Shire did not specify the nature of the information requested by the FDA, but remained confident Intuniv would eventually be approved.

When approved, Intuniv will be the first medication indicated to treat ADHD symptoms by selectively targeting alpha-2A-receptors in the prefrontal cortex, an area of the brain that is thought to manage executive functioning tasks, said Matthew Emmens, Shire’s chief executive officer.