Shire ADHD drug for UK
pharmafile | February 14, 2013 | News story | Sales and Marketing | ADHD, Shire, Vyvanse, elvanse
Shire’s attention-deficit hyperactivity disorder (ADHD) drug Elvanse has been given the go-ahead for use in the UK.
Elvanse (lisdexamfetamine dimesylate), marketed as Vyvanse in the US, can be used in children aged six and over when response to previous methylphenidate treatment is inadequate.
The single daily dose long-acting treatment has been authorised by the MHRA, the first stimulant prodrug to be launched in Europe for this behavioural psychiatric disorder which is thought to affect 3.62% of boys and 0.85% of girls aged between five and 15 in the UK.
The drug is ingested in an inactive form and then activated within the body, releasing its active element over time to help patients control their symptoms.
ADHD is one of the fastest-growing therapeutic categories in the US, where Vyvanse is Shire’s lead product, with 17% market share, despite the entry of additional generics into the market.
Sales of the drug grew 24% year-on-year in the third quarter of 2012 to $247 million, as a result of a 16% increase in prescription demand and a price hike. Shire’s latest figures are out today.
Dr David Williams, medical director at Shire UK, said the company was “committed to improving the understanding and treatment of ADHD”.
It is a complex disorder, with treatment generally including behavioural or other psychotherapies as well as medication.
Elvanse is thought to work by enhancing the availability of two neurotransmitters – noradrenaline and dopamine – to correct a presumed chemical imbalance and reduce inattention, impulsivity and hyperactivity.
MHRA approval was based on two European Phase III safety and efficacy studies in children and adolescents with ADHD as well as clinical data from the US, where it has been available since 2007.
The drug is also in use in Canada and Brazil, and the FDA is scheduled to decide in April whether Vyvanse should be used as a maintenance treatment in children and adolescents aged six to 17 with ADHD.
The drug is associated with a number of serious risks, some of which are fatal, and its prescribing information includes a warning about the potential for abuse.
Earlier this month Shire paid Impax $48 million to settle a legal dispute over another of its anti-hyperactivity drugs, Adderall XR.
Adderall has been steadily losing share in the face of generic competition and the manufacturer hopes that lisdexamfetamine dimesylate (LDX), the active ingredient in Vyvanse/Elvanse will be effective in other disorders.
Late-stage trials are ongoing in major depressive disorder and the company plans Phase III studies in binge eating disorder and in the negative symptoms of schizophrenia.
Adam Hill
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