FDA OKs New Use for AbbVie’s Humira
The US Food and Drug Administration has approved a new use for AbbVie’s top-selling drug, Humira (adalimumab), for treating moderate-to-severe hidradenitis suppurativa (HS), a chronic inflammatory skin disease. Humira had 2014 sales of $12.5 billion, accounting for 63%,of the company’s 2014 sales of $19.960 billion
Earlier this year, the FDA granted Humira orphan drug designation for the treatment of moderate to severe HS (Hurley Stage II and Hurley Stage III disease), a population of fewer than 200,000 patients. The orphan drug designation provides Humira the potential to be granted seven years of market exclusivity for the treatment of moderate to severe HS. In July, the European Commission approved Humira for treating active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic HS treatment in the European Union.
Since first gaining approval 12 years ago, Humira has been approved in more than 87 countries for several indications. It is approved for use in moderate to severe rheumatoid arthritis, ankylosing spondylitis, moderate to severe plaque psoriasis, active and progressive psoriatic arthritis, moderate to severely active Crohn’s Disease and moderate to severely active ulcerative colitis. Humira is approved in pediatric patients for use in enthesitis-related arthritis, severe plaque psoriasis, severe Crohn’s disease, and active juvenile idiopathic arthritis in patients who have had inadequate response to prior therapy.