EMA Recommends Approval of Shire’s ADHD Drug Intuniv

The European Medicines Agency has recommended approval of Shire’s Intuniv to treat attention deficit hyperactivity disorder — potentially breathing new life into the drug, which is facing new competition from generics in the U.S.

The positive nod comes less than three months after the FDA approved ANDAs for Intuniv manufactured by Sandoz, Mylan, Teva and Par Pharmaceuticals. All four companies have since launched their generic versions in the U.S.

Intuniv has patent protection in the EU until September 2025.

The EMA’s Committee for Medicines for Human Use based its recommendation on 13 studies, including five pivotal studies, showing the drug is safe and effective. The European Commission will now consider granting EU-wide approval.

Intuniv received FDA approval in 2009. Its patent doesn’t expire until September, but an April 2013 patent litigation agreement allowed Actavis to launch a generic version in December 2014, with 280 days of marketing exclusivity. That expired on May 30, opening the door for other generic competition. — Jonathon Shacat