4th Apr 2016 15:01
LONDON (Alliance News) - Shire PLC said Monday that it has seen positive topline results from a four week phase III study of its SHP465 compound for the treatment of attention deficit hyperactivity disorder in children and adolescents aged between 6 and 17 years.
Shire said this study addresses a key requirement from the US Food and Drug Administration to evaluate the safety and efficacy of the treatment before filing a resubmission for approval. This means SHP465 remains on track for a potential launch in the US in 2017.
"We are pleased with the positive results of the SHP465-305 study," said Head of Research and Development Philip Vickers in a statement.
"These results represent an important step toward a new treatment option for patients with ADHD. Shire looks forward to including these data as part of the FDA resubmission and is eager to continue advancing this clinical program," Vickers added.
Shares in Shire were up 2.3% at 4,177.00 pence Monday afternoon, one of the biggest gainers in the FTSE 100.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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