Shire plc, the global specialty biopharmaceutical company, has received a Complete Response letter for Intuniv (guanfacine) Extended Release from the Food and Drug Administration (FDA). This decision comes following labelling discussions with the FDA that did not result in agreement in time to meet the PDUFA date.
The FDA did not identify safety concerns regarding Intuniv in the Complete Response letter or request new clinical studies. Shire and the FDA will continue to work together to resolve the remaining labelling language over the next four to eight weeks.
"Shire is confident that we will quickly come to agreement on the final product label and anticipates a launch in the fourth quarter as planned," said Mike Cola, president of Shire Specialty Pharmaceuticals. "When approved, Intuniv will be the first selective alpha-2A receptor agonist for the treatment of ADHD, and will provide patients with an important new treatment option."
Intuniv is being studied for the treatment of ADHD in children and adolescents aged six to 17 years.
Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician.