Early Access to Arthritis Drug Offered in Europe

[peterb]

Early Access to Arthritis Drug Offered in Europe
Tue February 18, 2003 05:43 PM ET
By Richard Woodman
LONDON (Reuters Health) - Thousands of patients with rheumatoid arthritis will be offered Abbott's experimental therapy Humira (adalimumab) in early access programs before the potential blockbuster is approved in Europe, the company says.

In rheumatoid arthritis, the immune system attacks the tissues that line the joints, leading to pain, inflammation and deformity. Humira is an antibody designed to block a protein known as tumor necrosis factor (TNF), which plays a key role in inflammation.

The US Food and Drug Administration approved the drug this January. It is expected to be recommended for European Union approval by mid-year.

Abbott has two early access programs, the company's global medical director Elliott Chartash told reporters from Europe and South America at a two-day briefing on the drug last week.

Chartash said the first program was a 12-week open label, multicenter study to establish the safety and efficacy of Humira. At the end of the study, patients whose symptoms had improved by at least 20% could stay on the drug until it was available commercially.

In the second, physicians can request the drug on behalf of individual patients they believed would benefit from the therapy.

Both programs are available to patients in the United States, the European Union, Puerto Rico and Chile. Abbott's target is to have 7,500 patients enrolled by the end of the year, a company spokeswoman told Reuters Health.

In a telephone interview, Bill Dempsey, president of Abbott's International division, said the price was expected to be comparable to that of Enbrel, a similar drug. The drug price in the United States is around $13,500 per patient per year.

Abbott is also developing Humira for treating five other conditions, said Alejandro Aruffo, president of the bio-research center, including juvenile rheumatoid arthritis, Crohn's disease and psoriasis.

Humira is only approved for use at present in patients with moderate to severe rheumatoid arthritis who have an inadequate response to traditional disease-modifying anti-rheumatic drugs. However, the company is also doing trials in early-stage disease.

Charles Birbara, associate professor of medicine at the University of Massachusetts and clinical trials investigator of Humira, backed Abbott's claims that the key difference between Humira and similar drugs already being marketed is that Humira is the first fully human monoclonal antibody. This means there is less likelihood that patients will have injection reactions to the drug. Also, Birbara said, he has not seen the need to increase Humira dosage over time, though other similar drugs have shown this "dose creep."

[Cazzie]

That sounds really interesting. You have to get excited when they talk about these new ways of dealing with these frustrating conditions.  

[Val]

Rheumatoid arthritis, Crohn's disease and psoriasis.

Well as I have all three, this could be interesting to my GP, so I shall print that off and take it with me tomorrow. Thanks Peter.

Too right Cazzie, it's great to find out that these bod's are still looking for treatments that will work.