Shire’s non-stimulant ADHD drug approved in Europe

European marketing approval has been granted for Shire’s non-stimulant treatment for attention deficit hyperactivity disorder (ADHD).

Intuniv (guanfacine hydrochloride prolonged release tablets) is licensed for children and adolescents of 6 to 17 years old for whom stimulants are not suitable, not tolerated or have been shown to be ineffective.

Intuniv is only the second non-stimulant treatment for the condition, following Lilly’s off-patent drug Strattera.

Perry Sternberg, senior vice president, Neuroscience Business Unit, Shire said having a choice of non-stimulant ADHD treatments was important for doctors and patients.

“The importance of simply providing physicians with the ability to choose the non-stimulant option that may best suit the needs of their patients should not be overlooked, considering the complexities and different manifestations of the disorder in children and adolescents.”

Shire has built a market leading position in ADHD thank to its product Adderall, but the company has had to fight generic competition since its lead product went off-patent three years ago.

The firm’s next ADHD treatment, Vyvanse (known as Elvanse in Europe) was launched in 2013 and is now a blockbuster product. Further revenue growth is expected after the drug gained approval as the first ever treatment for binge eating disorder in February this year.

Even though Intuniv is a non-stimulant, there are still some serious potential side effects on the children and adolescents taking the drug.

The drug carries an increased risk of causing somnolence and sedation (predominantly at the start of treatment) as well as hypotension and bradycardia and QT-prolongation arrhythmia.

There is also a risk of increased weight or even risk of obesity, and healthcare professionals are instructed to monitor height, weight and BMI before treatment and at regular intervals thereafter.

Intuniv must also be used as a part of a comprehensive ADHD treatment programme, typically including psychological, educational and social measures.

The drug’s arrival in Europe is much delayed, as Shire first launched it in the US in 2009, where it has earned around $800 million a year. However the drug has faced generic competition from Actavis since 2013, with more generic versions being launched this year.

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