NDA filing planned by end of 2009; positive results from Phase III trials announced 12/08, 4/09; superior to interferon beta-1a 5/09; 2yr data reported 9/09 shows both primary and secondary endpoints met with statistical significance achieved compared to placebo; positive data published in NEJM 1/10; FDA grants priority review (2/10), but June PDUFA date may likely be delayed, as FDA will likely want an advisory board (2/10); positive data presented to AAN shows drug prevented relapse in 62% of tx-naïve patients, while relapse rates were reduced by 44% in those who'd already received other treatments (4/10); FDA advisory board scheduled for 6/10/10 and PDUFA date extended to 9/21/10; FDA advisory board recommends drug 6/10, but will require Novartis to study a lower dose for future release
Brand Gilenia Generic fingolimod (FTY720)
Company name Novartis Product type Speciality
Therapeutic category Immunologic agents Key uses Multiple Sclerosis (MS)
Other Uses N/A Drug Class sphingosine 1-phosphate (S1-P) receptor modulator
Dosage From oral Expected Approval 2010-Q3
FDA Filing 12/09 Last Update date June 14,2010
Link to published study
Link to news article
Link to emerging technology assessment
Link to clinicaltrials.gov
Link to press releases