Humira gets go-ahead for the treatment of ankylosing spondylitis
pharmafile | June 9, 2006 | News story | Sales and Marketing |Â Â Â
Abbott has been given the green light to market Humira in Europe for the treatment of severe active ankylosing spondylitis.
This news means the drug now has three approved indications for autoimmune disease as it already has European Commission approval for severe active and progressive rheumatoid arthritis, and psoriatic arthritis.
Humira (adalimumab) will now be chasing Wyeth's current market TNF-blocker leader, Enbrel (etanercept), and Schering-Plough's Remicade (infliximab), both of which already have Commission approval for the treatment of ankylosing spondylitis (AS).
Last year, Enbrel continued its market lead with sales of $3.6 billion a 42% growth rate over 2004's sales. Remicade also had increased sales, earning $2.8 billion, while Humira notched up sales of $1.4 billion.
Fergus Rogers, president of the National Ankylosing Spondylitis Society, said that European approval for Humira for the treatment of AS would greatly enhance patients' quality of life.
He said: "The use of the anti-TNF class of treatments is, in my opinion, the biggest breakthrough in the history of the treatment of AS. Therapies such as adalimumab are greatly improving the quality of life of those who are receiving them."
The approval of Humira for AS follows the positive opinion granted by the EMEA in April, based on data from a trial by ATLAS (Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS), which comprised a randomised, placebo-controlled, double-blind phase III study conducted in Europe and the US.
Results from the trial indicated that Humira reduced pain and inflammation in patients, and it also induced partial remission of the disease in some sufferers.
"This approval of Humira in the EU is important in the treatment of AS," said Desiree van der Heijde, co-lead investigator of the ATLAS phase III trial and professor of rheumatology at Maastricht University, the Netherlands. "Treatments like Humira are changing how we can treat AS; the data in the clinical trial showed that Humira significantly reduced pain and inflammation and, in some patients, led to partial remission."
Humira will be available immediately to patients in Germany, Spain, Finland and Denmark, with availability in other EU countries taking place in the coming months as each country adopts its own pricing and reimbursement policies. Abbott's US application for Humira is currently under review.
