Initial results from the one year phase III transforms study show the investigational oral compound, FTY720 (fingolimod) has superior efficacy to a current standard of care for patients with relapsing-remitting multiple sclerosis (MS).
Patients on oral FTY720 experienced significantly fewer relapses than those treated with the injectable medicine interferon beta-1a (Avonex)
The study, the first one year head to head phase III trial against a standard of care in MS, met its primary endpoint for both doses of FTY720.
Comprehensive analyses of the transforms study data are ongoing, and detailed results are planned to be presented at a leading scientific congress in 2009. Regulatory submissions remain on track to be completed in the US and EU at the end of 2009.
“We are encouraged by the early results from transforms, which represent a major step towards delivering an effective oral treatment for people with relapsing-remitting MS,” said Trevor Mundel, Global Head of Development at Novartis Pharma AG.
“These positive results reinforce the potential for FTY720 to provide a significant advance in the future treatment of this devastating disease.”
MS is a chronic autoimmune neurodegenerative disease of the central nervous system associated with irreversible progression of disability. As many as 2.5 million people worldwide are affected by the condition that typically begins in early adulthood between the ages of 20 and 40 years when patients are in the prime of life.