FTY720 (fingolimod), a novel oral development therapy for multiple
sclerosis, showed continued low relapse rates after four years in
patients with relapsing-remitting MS in an open-label Phase II
extension study. The data, presented at the American Academy of
Neurology (AAN) meeting in April, also showed no significant change
in the safety profile from three to four years. Data at AAN from
TRANSFORMS, a one-year Phase III trial against interferon beta-1a
(Avonex®), showed 80-83% of MS patients given FTY720 were
relapse-free for one year compared to 69% of patients treated with
Avonex® (p<0.001), with a safety profile for FTY720 in line with
previous experience. US and European regulatory submissions are
expected by the end of 2009. Initial results of the Phase III
placebo-controlled FREEDOMS trials are also expected in the fourth
quarter of 2009.
So, it still sounds like it's set for submission later this year, but then who knows how long the approval process will take assuming it will even get FDA approval?