The FDA has given the nod to Mydayis (mixed salts of a single-entity amphetamine product, Shire), a once-daily treatment consisting of three different types of drug-releasing beads for patients 13 years of age and older with attention-deficit/hyperactivity disorder (ADHD).
Shire has previously suggested the new drug would be its most important 2017 launch and could be worth around $500m a year in peak sales, although consensus analyst estimates a more modest $288m by 2020, mainly because of anticipated payer resistance in the USA as the new drug has the same ingredients as Adderall XR. Shire, Mydayis' manufacturer, stated in a press release that the medication would become available to consumers in the third quarter of 2017.
Shares in the FTSE 100 company rose around 1.5pc in trading as investors digested the news.
"Mydayis is the latest innovation in Shire's 20-year legacy of helping to support the treatment of ADHD". Jefferies analysts noted that every ADHD drug launched by Shire has significantly exceeded initial market projections.
ADHD is characterised by inattention either with or without hyperactivity-impulsivity.
Dr Ornskov said with the approval, Shire hoped to help patients who needed a once-daily treatment option. According to some estimates up to 11% of children in the U.S. are affected and more than half continue to suffer from the disorder in adulthood.
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With its acquisition of Baxalta past year, Shire has been building a presence in rare diseases, but ADHD is still a major part of its business.
Both Mydayis and Adderall XR contain amphetamine, a stimulant that elevates levels of dopamine - a neurotransmitter associated with motivation, attention and movement.
Mydayis is created to help eliminate the use of short-acting stimulants given to boost the impact of long-acting ones, especially among college students and adults, Mattingly said. Mydayis is not for use in children 12 years and younger. Non-stimulant ADHD treatments have fewer side-effects but are typically less effective.
Shire first filed an application to market Mydayis in 2006 but faced multiple setbacks, including a requirement for additional studies to satisfy the FDA.
Other ADHD drug developers include Neos Theraputics Inc, Alcobra Ltd and Aevi Genomic Medicine.
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