9th Oct 2014 08:40
LONDON (Alliance News) - Shire PLC Thursday said the US Food & Drug Administration has requested more pediatric data before a new drug application for its adult attention-deficit and hyperactivity disorder treatment SHP 465 can be re-submitted, a request that will impact its plans for making the re-submission this year.
In a statement, the company said it had received further guidance from the FDA on the regulatory path for SHP465, an investigational oral stimulant medication being evaluated as a potential
treatment for ADHD in adults.
In April, the FDA had written to Shire confirming that the company could submit SHP 465 as a
so-called Class 2 resubmission after it made a package of proposals. However, after a series of follow-up talks, the FDA clarified that further pediatric data would be required, Shire said.
The company didn't give the details of its new plans for re-submitting the new drug application.
Shire shares were up 1.5% at 5,382.50 pence early Thursday.
By Steve McGrath; [email protected]; @stevemcgrath1
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