Shire’s Venvanse accepted for EU review by MHRA

Shire has announced that its attention deficit hyperactivity disorder (ADHD) therapy Venvanse has been accepted for European regulatory review.

The UK's Medicines Healthcare Products Regulatory Agency (MHRA) has agreed for Britain to act as the reference member state for the decentralised procedure, which will apply to eight EU nations initially.

Venvanse has already been successfully commercialised in the US and Canada as a therapy for children, adolescents and adults with ADHD, under the alternative brand name Vyvanse.

The drug has also proven its efficacy among children and adolescents in a European phase III study, which will help to support the new regulatory submission.

Mike Yasick, senior vice-president of Shire's ADHD business unit, said: "The regulatory submission of Venvanse in Europe is an important milestone for Shire and for physicians in the EU who are seeking alternative treatments to help their patients diagnosed with ADHD."

This comes after phase II data published last month showed the drug also demonstrates promise as a therapy for major depressive disorder.