Shire launches non-stimulant ADHD treatment in UK
Intuniv, a new non-stimulant treatment for attention deficit hyperactivity disorder (ADHD) in children and adolescents aged 6-17 years old has been launched in the UK.
The once-daily treatment is marketed by Shire, which has grown strongly over the last 20 years thanks to a succession of ADHD treatments such as Adderall XR (now off patent) and rare disease treatments, including Elaprase.
Vyvanse is the Shire's biggest selling ADHD treatment, and biggest brand overall, earning around $1.7 billion in 2015.
But stimulant-based drugs such as these are not suitable for all children with the condition. Intuniv (guanfacine) is licensed in Europe for children for whom stimulant-based ADHD medications are not suitable, not tolerated or have been shown to be ineffective.
Guanfacine prolonged release tablets are not a central nervous system stimulant but a selective alpha-2A adrenergic receptor agonist.
Until today, there was only one licensed non-stimulant treatment available in Europe, Lilly's Strattera (atomoxetine), which has now gone generic.
Shire has been one of the busiest players in the pharma M&A market over the last 12 months, and clinched the takeover of fellow rare disease firm Baxalta in January for $32 billion.
While Intuniv sales are expected to be relatively modest, Shire predicts sales of its next launch to exceed $1 billion by 2020. Lifitegrast could be the first treatment for dry eye disease to reach the market. However the drug was rejected by the FDA in October because it had failed to hit a major trial endpoint. Shire has now submitted data from five clinical trials, and the FDA is set to announce its decision on the new submission on 22 July.
Shire also has a new ADHD treatment in late-stage development, SHP465 (triple-bead mixed amphetamine salts - MAS). The company wants to target the drug at adults with the condition, but an FDA request for trials in children has delayed its filing.
Pending FDA approval, Shire says it anticipates launching the medicine in the second half of 2017.