The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has granted a positive opinion for Abbvie’s Humira (adalimumab) for the treatment of moderately to severely active Crohn’s disease in pediatric patients (from six years of age) who have had an inadequate response to conventional therapy, including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.

Humira is currently approved in the European Union for the treatment of severe active Crohn’s disease in pediatric patients (from six years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy, a corticosteroid, and an immunomodulator, or who are intolerant to or have contraindications for such therapies.

The review is being conducted under the centralized licensing procedure. If approved, the authorization will be valid in all 28 member states of the European Union, as well as Iceland, Liechtenstein, and Norway.

Since first gaining approval more than 13 years ago for rheumatoid arthritis, Humirahas been approved in more than 90 countries and is currently being used to treat more than 955,000 patients worldwide across 13 globally approved indications. It was AbbVie’s top-selling drug in 2015 with global sales of $14 billion. 

Source: AbbVie