The US Food and Drug Administration (FDA) has accepted Shire plc's Vyvanse (lisdexamfetamine dimesylate) capsules supplemental New Drug Application (sNDA) filing for review.
Shire is seeking approval of Vyvanse as a maintenance treatment in children and adolescents ages six to 17 years with Attention-Deficit/Hyperactivity Disorder (ADHD).
There are currently no stimulants approved for maintenance treatment in children and adolescents ages six to 17 years with ADHD. The FDA has issued a Prescription Drug User Fee Act (PDUFA) action date of April 29, 2013.
“Shire is committed to furthering knowledge about ADHD and the ways in which this disorder can be treated,” said Jeffrey Jonas, MD, senior vice president of Research and Development for Shire’s Specialty Pharmaceuticals and Regenerative Medicine Businesses. “This filing is important because only minimal data exist in children and adolescents assessing the maintenance of efficacy with a stimulant medication versus a placebo.”
Shire is seeking approval for maintenance treatment in children and adolescents ages six to 17 with ADHD based on the results of a clinical study (SPD489-326), a phase III b, randomized withdrawal, multicenter, extension study to evaluate the long-term maintenance of efficacy and safety of Vyvanse. This study was also included in the European Marketing Authorization Application (MAA) submission package for approval of lisdexamfetamine dimesylate in Europe.
Vyvanse is a prescription medication currently approved in the United States for the treatment of ADHD in patients ages six to 17 and adults as part of a total treatment plan. Vyvanse is also approved in the United States as a maintenance treatment for adults with ADHD. Extended use of Vyvanse should be periodically reevaluated to determine its long-term usefulness for the individual patient.
Vyvanse is a Schedule II controlled substance. Stimulants, such as amphetamines and methylphenidates, are subject to misuse, abuse, addiction, and criminal diversion. Misuse of amphetamines may cause sudden death and serious cardiovascular adverse events.
Vyvanse is also approved in Canada (in patients six years and above), as well as in Brazil (patients six to 12 years) under the name Venvanse, for the treatment of ADHD.
Vyvanse, was introduced in the United States in July 2007 for the treatment of ADHD in children ages six to 12 years, approved in April 2008 to treat ADHD in adults, approved in November 2010 to treat ADHD in adolescents ages 13 to 17, and approved in January 2012 for maintenance therapy in adults.
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician.