How long does it take to develop a DMT?

The following is fingolimod's time-line. This is typical example how long it takes to develop a DMT for MS. If the PPMS trial is positive fingolimod will only be available for people with PPMS in late 2014 or early 2015.


"Is it fair to make people with PPMS wait this long?"


  1. 1992: Fingolimod (FTY720) first synthesized by Japanese scientists
  2. 1997: Fingolimod in-licensed by Novartis for clinical development
  3. 1998: First studies in man (Phase 1 trials) and subsequent start of transplantation trials
  4. 2003: Start of MS Phase II trial
  5. June 2005: Presentation of Phase II study results followed by publication in NEJM 2006
  6. Jan 2006: Start of Phase III FREEDOMS study in RRMS
  7. May 2006: Start of Phase III TRANSFORMS study in RRMS
  8. June 2006: Start of Phase III FREEDOMS II study in RRMS
  9. July 2008: Start of Phase III INFORMS trial to assess suitability for treatment of PPMS
  10. Dec 2008: Release of TRANSFORMS study results and presentation at AAN April 2009
  11. Sep 2009: Release of FREEDOMS study results and presentation at AAN April 2010
  12. Dec 2009: Regulatory submission to FDA and EMA (ROW submissions in Q1 2010)
  13. Feb 2010: Results of Phase III TRANSFORMS & FREEDOMS studies published in NEJM
  14. Sep  2010: Approval by Russian Health Authority
  15. Sep 2010: Approval  by the US FDA for relapsing MS
  16. Jan 2011: Approval by the European Medicines Agency for highly-active relapsing MS
  17. April 2011: Licensing approval in the UK for highly-active relapsing MS
CoI: I have received personal compensation from Novartis for being a member of the phase 4 fingolimod development programme and our centre is one of the sites participating in the phase 3 PPMS trial.