Fingolimod Gets Initial Approval of FDA Committee

13 June 2010 (Last Updated June 13th, 2010 18:30)

Multiple sclerosis drug fingolimod (FTY720) has received approval from a US Food and Drug Administration (FDA) expert advisory committee as a treatment for relapsing/remitting multiple sclerosis. The committee also approved the safety of the proposed 0.5mg FTY720 dose, but recommended th

Multiple sclerosis drug fingolimod (FTY720) has received approval from a US Food and Drug Administration (FDA) expert advisory committee as a treatment for relapsing/remitting multiple sclerosis.

The committee also approved the safety of the proposed 0.5mg FTY720 dose, but recommended that more safety data is collected post-marketing and a lower dose evaluated.

The committee studied data from the drug's clinical trial programme, which compared its ability to reduce relapses, slow disability progression and brain lesions with commonly prescribed treatments and placebos.

The drug still needs final approval from the regulator. If approved, it will become the first oral therapy for treating relapsing/remitting multiple sclerosis.

The FDA is expected to make a decision on regulatory approval for FTY720 by September 2010.