9th Oct 2014 08:47
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 specialty biopharmaceutical company which is in the process of being acquired by Abbvie Inc in a deal valuing it at GBP32 billion, 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 one daily 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.
In July, Shire had said it would spend money in the second half of this year on the anticpated launch of SHP465 in the US.
Shire shares were up 1.6% at 5,390.00 pence early Thursday.
By Steve McGrath; [email protected]; @stevemcgrath1
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