Novartis hails new MS pill as a breakthrough
pharmafile | June 23, 2005 | News story | Sales and Marketing |Â Â Â
Novartis says its new multiple sclerosis treatment is more effective than existing drugs in delaying the progress of the disease, and is far more convenient for patients.
New phase II data shows FTY720 reduced the rate of clinical relapses by more than 50% and inflammatory disease by up to 80% over six months compared to placebo.
Current MS therapies have an average reduction in relapse rates at about 30% (these can be as high as 50%) suggesting that Novartis' new drug is significantly superior.
The oral medication also bypasses the need for frequent injections with existing drugs, which are needed at least once a week although daily injections are required in some cases.
FTY720 is a once-daily pill and is the first in the sphingosine-1-phosphate (S1P) receptor modulator class.
S1P receptors are present on the surface of lymphocytes, which are a subpopulation of blood cells. In MS, lymphocytes circulating in the central nervous system attack the myelin sheath that protects nerve fibres, causing irreparable damage.
Novartis' drug blocks the signal to the lymphocytes instructing them to circulate to sites of inflammation, and thus prevents them from causing the damage. The lymphocytes nevertheless remain functional and may still be activated within the lymph nodes as part of the immune response.
"FTY720 has shown significant and consistent effect on both clinical relapses and MRI measures in just six months. With its novel mode of action and the added benefit of an oral formulation taken once daily, further clinical development of FTY720 might have a major impact on the way we treat MS in the future," said Professor Ludwig Kappos of University Hospital, Basel in Switzerland.
"We hope that the magnitude of benefits shown in phase II will be confirmed in the larger scale phase III study programme."
The phase III programme is expected to be launched in the fourth quarter of 2005 involving centres in North America and Europe. FTY720 is also being developed for use in renal transplantation.
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