Please login to the form below

Not currently logged in
Email:
Password:

Humira gets green light in EU for ulcerative colitis

Abbott’s self-injectable drug on course to overtake Lipitor and Plavix as world’s biggest seller

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.

12th April 2012

Share

Related Hub content

    Your search did not contain any words. Please try again.

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Health4Brands

At H4B, we are an energetic new team with fresh ideas, but we have over 275 years of combined experience...

Latest intelligence

More of the same: The importance of strategic communications planning for biosimilar entry
GCI Health's Hannah Morris considers the importance of strategic communications planning for biosimilar entry, a market anticipated to deliver between €8-26bn in savings across the European Union by 2020....
Online Physician Communities
How can pharma realise the power of digital?
Firstly, by making it owned and driven by the most senior leadership team in the business...
Remapping the market: Does Pharma's global model need a shake up?
For patients, carers and professionals, wherever they are in the world, digital technology is inherent in their everyday lives. Digital is, so to speak, a global language. The success of...