Abbott Laboratories' says its Humira product has become the first and only self-injectable biologic therapy to be approved for ulcerative colitis in the EU, opening up a major new market for the drug.
The approval is for use of Humira (adalimumab) as a second-line therapy in adults with moderately- to severely active ulcerative colitis, and was based on two phase III clinical trials involving more than 800 patients in 21 countries, according to the company.
The new indication is the seventh for Humira and puts the product on track to become the biggest-selling drug in the world as generic competition takes its toll on the current top products, Sanofi/Bristol Myers Squibb's Plavix (clopidogrel) and Pfizer's Lipitor (atorvastatin).
Sales of Humira reached $7.93bn last year, up 21 per cent over 2010, and analysts predict that the new approval will help it top $9bn in 2012.
That sales growth bodes well for the near-term prospects for AbbVie, the research-based pharmaceutical company that Abbott is due to spin out later this year.
Ulcerative colitis "is a difficult-to-treat chronic disease with limited treatment options," according to William Sandborn of the UC San Diego Health System, the lead investigator in Abbott's pivotal trial programme for Humira.
"A new therapeutic option used for the induction and maintenance of remission, with the convenience of self-administering at home is welcomed among this unique patient population," he added.
Last year, Abbott reported that Humira achieved a remission rate of 16.5 per cent among ulcerative colitis patients who had failed prior treatment with conventional drugs such as corticosteroids and immunosuppressants, compared to 9.3per cent of those given placebo.
It will compete in the ulcerative colitis segment with Merck & Co/Johnson & Johnson's Remicade (infliximab), as well as follow-up Simponi (golimumab) and Pfizer's Enbrel (etanercept).
Also coming through the late-stage pipeline is Takeda/Millennium's vedolizumab, which reported positive phase III data in February, and Pfizer's tofacitinib.