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Shire shares rise as US FDA approves use of longer term ADHD drug Mydayis

04:38 EDT 21 Jun 2017 | Proactive Investors

Shire PLC (LON:SHP) shares rose this morning as the US Food and Drug Administration approved its longer-term use Attention Deficit and Hyperactvity Disorder (ADHD) drug, Mydayis as a once a day pill for patients 13 years old and above. The FTSE 100-listed company said, following the approval, it expects the drug to become available in the US in the third quarter of this year. The approval comes after results from 16 clinical studies evaluating Mydayis in more than 1,600 subjects with ADHD demonstrated improvements lasting up to 16 hours after dosage. READ: Shire reports better than expected first-quarter results boosted by Baxalta acquisition Mydayis contains the same active ingredient as the company's widely used ADHD treatment Adderall XR but is formulated to last longer. ADHD is characterised by inattention either with or without hyperactivity-impulsivity. According to some estimates up to 11% of children in the US are affected and more than half continue to suffer from the disorder in adulthood. In a note to clients, analysts at Cantor Fitzgerald reiterated a 'buy' on Shire shares, saying that the Mydayis approval "repesents an important life cycle management product for Shire as it seeks to generate some longevity for its long standing stimulant franchise." They added: "Given Shire’s prowess in the ADHD market, we believe that Mydayis can be a meaningful product, particularly in those who already top up a long acting therapy. With Shire’s leading branded ADHD treatment Vyvanse still enjoying a further 6+ years before generic competition in the US, it will be interesting to see what proportion of the US ADHD market that Mydayis can capture." In early morning trading, Shire shares were up 0.9%, or 37.5p at 4,408.0p  

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