AbbVie Receives FDA Approval for Additional Indication of Humira

AbbVie has received US Food and Drug Administration (FDA) approval for another indication for Humira (adalimumab) for reducing signs and symptoms, and achieving and maintaining clinical remission, in pediatric Crohn’s disease patients six years of age and older when certain other treatments have not worked well enough. This FDA approval represents the eighth indication for Humira in the United States.

Humira is AbbVie’s top-selling drug which accounted for nearly $10.7 billion, or 57% of the company's total revenues of $18.79 billion in 2013. Humira is indicated for treating rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis. The United States composition of matter (i.e., the compound) patent covering adalimumab is expected to expire in December 2016, and the equivalent European Union patent is expected to expire in the majority of European Union countries in April 2018.

In 2012, the European Commission approved Humira for the treatment of pediatric patients 6 to 17 years of age with severe active Crohn’s disease who failed, are intolerant to, or have contraindications to conventional therapy.

Source: AbbVie

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