LONDON, June 12 London-listed drugmaker Shire
PLC said it had agreed to a request from the U.S.
regulator to test the use of its amphetamine-based drug Vyvanse
in preschool children aged four and five with hyperactivity.
The FDA, the U.S. regulator, says the drug should be
prescribed for patients aged six years or above.
Shire said the additional efficacy and safety data from the
trials would help clinicians and parents make informed treatment
decisions for preschool-age children with ADHD (attention
deficit hyperactivity disorder).
The condition is increasingly diagnosed in U.S.
schoolchildren, and worldwide sales of the drug grew 18 percent
in the first quarter to $351 million.
Shire said the estimated prevalence of ADHD in the preschool
population was three to five percent, and data suggested that
only a small proportion of them responded adequately to
It said it anticipated beginning the first trial in its
preschool pediatric clinical trial program in the first half of
(Reporting by Paul Sandle; editing by Sarah Young)