Oral Pill Fingolimod Reduces Relapses And Disability Progression

Main Category: Multiple Sclerosis
Also Included In: Clinical Trials / Drug Trials
Article Date: 01 Oct 2009 - 3:00 PDT

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Drug manufacturer Novartis has announced further results from its phase III study of the oral pill fingolimod (FTY-720) in people with relapsing remitting multiple sclerosis (MS).

The results are from a two-year phase III study called FREEDOMS trial and show that the tablet can reduce relapses by up to 60% and disability progression by up to 32% in people with relapsing remitting MS.

The results build on trial data announced earlier in the year that showed a reduction in the number of relapses by about 58% in participants taking fingolimod compared to interferon-beta-1a, a standard injectable therapy for the treatment of relapsing remitting MS.

The latest trial, which involved 1272 participants with relapsing remitting MS, analysed two varying doses of FTY-720 but found that there is no difference in effectiveness. As a result a lower dose will be recommended for use, bringing with it less serious side effects.

MS Society Head of Research, Dr Lee Dunster, said: "The availability of oral therapies will herald a new dawn for people with MS and if trial results satisfy the regulator there could be a real alternative to incovenient and unpleasant injections."

Novartis has announced its intention to submit a license application for fingolimod at the end of the year on the basis of the recent results. Once submitted, the application would be subject to regulatory approval and evaluation by government drug regulator the National Institute for Health and Clinical Excellence (NICE).

Fingolimod is one of two oral therapies currently being developed. Swiss firm Merck Serono is currently trialling cladribine and will apply for a licence this year.

Should the applications be approved, people with MS could see the therapies available late next year.

Source
Multiple Sclerosis Society