AbbVie is facing up to the likelihood it won’t be able to expand the use of its biggest selling drug Humira in the US after an advisory panel to the US Food and Drug Administration (FDA) voted against an additional indication.
The panel, which advises the FDA, voted 12 to 1 that Humira (adalimumab) should not be available to market in the US for the treatment of spondyloarthritis – an inflammatory disease that affects the spine and causes back pain and swelling.
Instead, the panel of advisers requested that AbbVie conduct additional trials to support the efficacy of the drug in this condition, which is estimated to affect as many as 2.7 million adults in the US.
The FDA doesn’t have to accept the panel’s recommendation, but it often does, and a negative decision would be a blow for AbbVie as it looks to make the most of Humira’s potential before the drug’s patent expires in 2016.
Humira is already a huge seller, notching up more than $9bn during 2012 in its current autoimmune indications for rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis, Ankylosing spondylitis and Crohn’s disease.
However, AbbVie must handle both the looming threat of generic competition and new anti-inflammatory products, such as Pfizer’s Xeljanz (tofactinib citrate) and Bristol-Myers Squibb’s Orencia (abatacept), with these likely to impact Humira sales.
Nevertheless, the company is still positive for the drug’s immediate future, stating in its inaugural guidance following its spin-out from Abbott in February this year that Humira sales in emerging markets will help to overall spur growth.
In Europe, Humira was approved for use in severe axial spondyloarthritis in July 2012, making it the first and only approved medication available for non-radiographic form of the condition.