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Breakthrough MS drug tipped for blockbuster status

Published on 30/11/04 at 10:17am

The US has approved Tysabri, an innovative new drug which could offer new hope for sufferers of multiple sclerosis and eventually earn its marketers over $1 billion a year.

Trial data suggests Biogen Idec and Elan's Tysabri (natalizumab) is significantly more effective than existing treatments in preventing MS patients suffering relapses in their condition.

The FDA gave the drug a fast track review and has now granted its manufacturers a licence to treat relapsing forms of MS, even though two key studies are ongoing.

The trials showed the drug reduced the rate of clinical relapses by 66% compared to placebo and that combined with existing MS drug Avonex, produced a 54%  reduction in relapses compared to the older drug on its own.

James Mullen, chief executive officer, Biogen Idec claimed the new drug would revolutionise the treatment of MS and become the leading choice for patients and physicians.

Kelly Martin, president and chief executive at Elan added: "The approval of Tysabri, with its unique mechanism of action and new level of efficacy, has the potential to make a genuine difference in the lives of patients and families who struggle with the debilitating effects of this disease."

The drug was submitted to the EMEA in June this year based on data from one-year clinical trials with a decision expected by early 2005.

Analysts Deutsche Bank predict Tysabri will reach sales of $843 million within just two years, eventually overtaking established products including current market leader, Biogen's Avonex which earned $1.2 billion in 2003.

Tysabri, a humanised monoclonal antibody works in a different way to MS drugs currently on the market by inhibiting dhesion moleculeson the surface of immune cells.

Research suggests this action prevents immune cells from travelling to the brain where they can cause inflammation and potentially damage nerve fibres and their insulation.

The AFFIRM trial found 76% of patients remained free from relapses compared to 53% in the placebo-treated group and in the SENTINEL trial 67% of patients remained relapse-free in the Tysabri and Avonex -treated group compared to 46% in the Avonex plus placebo-treated group.

Researchers think the drug could prove useful in a broad range of patients with MS, including those who have discontinued therapy, are newly diagnosed with MS, or have persistent active disease despite being on a current therapy.

Two-year results from both studies are expected to emerge early in the New Year, following which enrolment for a long-term safety extension study will begin.

The treatment has shown potential for some serious side-effects, including one that sees its effectiveness reduced but the FDA was satisfied these cases were relatively few.

The potential of the drug extends beyond MS, and in September the marketing partners filed for a licence to treat Crohn's disease, a disease area being targeted by competitors in the TNF-blocker market including, Abbott's Humira.


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