Batch of EMA/CHMP recommendations, including Intuniv

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization for Ireland-headquartered Shire’s (LSE: SHP) Intuniv (guanfacine) to treat attention deficit hyperactivity disorder (ADHD) in children and adolescents aged six to 17 years old for whom stimulants, another type of ADHD medicines, are not suitable or tolerated or have shown to be ineffective.

In its scientific opinion, the CHMP stressed that Intuniv, like other medicines authorized for the treatment of ADHD, must only be used as part of a comprehensive treatment program typically incorporating psychological, educational and social measures. The CHMP also recommended that treatment with Intuniv must be initiated under the supervision of an appropriate specialist in childhood and/or adolescent behavioural disorders.

Intuniv is the first treatment for ADHD in the European Union to be recommended through the centralized authorisation procedure. The drug is already approved and marketed, and lost its patent protection in its biggest market, the USA, last year, leading to a second-quarter 91% decline to $9.5 million year on year as a result of generic competition.