Humira gains European licence for ulcerative colitis
pharmafile | April 11, 2012 | News story | Sales and Marketing | Humira, ulcerative colitis
Abbott’s Humira has gained European approval to treat ulcerative colitis, adding to its six existing licences.
It can now be used for the treatment of moderately to severely active ulcerative colitis (UC) in patients who have had an inadequate response to standard therapies, such as J&J’s Remicade.
The approval makes Humira (adalimumab) the first and only self-injectable biologic therapy for the treatment of moderately to severely active UC. It also represents the seventh indication for Humira in the European Union since the product’s first approval in 2003.
It already has licences for a number of inflammatory diseases, including rheumatoid arthritis, Crohn’s disease and psoriatic arthritis.
UC is a chronic inflammatory bowel disease that causes ulcers in the colon and may lead to life-threatening complications. It is estimated that the disease affects up to 1.2 million people in the European Union.
The approval was based on two Phase III clinical trials involving more than 800 patients in 21 countries. The most recent study showed that of the patients treated with Humira, 16.5% achieved clinical remission compared to 9.3% on placebo at week eight.
This increased to 17.3% after a year compared to 8.5% on placebo, meaning the drug met its trial endpoint.
“The approval of Humira for the treatment of moderately to severely active ulcerative colitis further demonstrates the drug’s versatility in treating a wide range of immune-mediated inflammatory diseases,” said John Leonard, senior vice president of pharmaceuticals R&D at Abbott.
Humira is expected to become the world’s biggest selling drug this year after the patent loss of Pfizer’s blockbuster Lipitor. Abbott’s drug made $7.9 billion in sales in 2011 and this should be boosted by its new UC licence in Europe.
But Decision Resources believe that the UC market will only grow by around $700 million between 2009 and 2019, from $1.1 billion to $1.8 billion.
This market includes the anti-TNF drugs Remicade and J&J/Merck’s Simponi, as well as Takeda’s vedolizumab, which is currently undergoing Phase III trials.
Decision Resources said this growth would be curbed by ongoing monitoring and cost containment costs, given the high price of biologics.
Ben Adams
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