Shire’s extended-release version of non-stimulant Intuniv is a giant step closer to entering the European market after being recommended for approval as a treatment for children and adolescents with attention-deficit hyperactivity disorder.
The Committee for Medicinal Products for Human Use has adopted a positive option on the drug on the back of three clinical trials investigating its short and long-term safety and efficacy profile, which showed significant improvements in ADHD symptoms.
If approved in Europe, Intuniv (guanfacine hydrochloride extended release) will be indicated for the treatment of ADHD in children and adolescents six to 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective.
Meanwhile, the firm reported second-quarter results this week, posting flat group revenues of $1.56 billion (up 9% at constant exchange rates).
The Dublin, Ireland-headquartered group recorded an 18% rise increase in sales of ADHD drug Vyvanse to $425 million, but turnover of Intuniv plummeted 91% to just $9.5 million because of generic competition in the US.
Operating income (non-GAAP) slipped 3% to $614 million.