The European Commission (EC) has approved Abbott's Humira for expanded use in the inflammatory disorder Crohn's disease (CD).
The drug is now available for the treatment of moderately active CD in adult patients who have had an inadequate response to conventional therapy, adding to its existing CD indication for the treatment of severely active CD in adults.
The new approval opens up a larger CD market for Abbott, with the condition thought to affect up to 1m people in Europe.
Humira is already approved in a number of inflammatory indications, including rheumatoid arthritis, psoriatic arthritis and ulcerative colitis, and this latest indication should secure the drug's place as one the world's biggest selling medicines, with Abbott reporting revenues of $3.4bn in the US alone during 2011.
Dr Paul Rutgeerts, chair of the inflammatory bowel diseases group at University Hospital Gasthuisberg in Leuven, Belgium, commented on the benefits for people with CD, with particular reference to the fact that patients can inject the drug themselves compared to rival CD treatment Remicade (infliximab) from Janssen, which must be administered by a doctor.
He said: "This label extension provides more patients access to a convenient, self-administered therapeutic option."
Humira has also been shown to induce and maintain clinical remission in adult patients with moderately to severely active CD in four phase II/III trials.
There was further good news for Abbott's Humira ambitions this week, with an advisory panel for the US Food and Drug Administration (FDA) voting 15-2 in support of the drug's use in patients with moderate to severe ulcerative colitis who don't respond to conventional therapies.
Taking into account Humira's simpler method of use to other treatments, the panel determined that the drug's benefits outweighed its risks, although the panel also voted 14-3 in agreement with the FDA's assessment that Abbott has still to find the right dosage for the drug in treating CD.
The FDA is due to make its decision on whether to approve Humira for the ulcerative colitis in September, 2012.
Abbott is also pushing for the drug's approval in several other indications ahead of its patent expiry in 2016, with inflammatory bowel disease and paediatric Crohn's disease priorities as potential options.