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Sarepta's Eteplirsen demonstrates stability on pulmonary function

  • Sarepta Therapeutics' (SRPT +3.4%) Eteplirsen treatment for Duchenne muscular dystrophy demonstrates stability on pulmonary function tests through 120 Weeks in a Phase IIb Study of twelve boys aged 7-13 years.
  • In the age group tested, pulmonary function would be expected to drop over the analysis period, says Sarepta's Edward Kaye. The results "provide early evidence towards achieving a key treatment goal, the delay or avoidance of pulmonary ventilation assistance in DMD patients."
  • The results add to data showing a general stabilization of walking ability in Eteplirsen-treated patients. (PR)
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Comments (4)
  • pat walsh
    , contributor
    Comments (282) | Send Message
     
    The FDA will not approve drug until the kids can run a 26 mile marathon and GSK gives permission.
    5 Feb 2014, 10:26 AM Reply Like
  • Mongoose7916
    , contributor
    Comments (230) | Send Message
     
    The FDA has to approve the drug. The question is whether they give accelerated approval or not?
    5 Feb 2014, 12:53 PM Reply Like
  • rrobster
    , contributor
    Comments (146) | Send Message
     
    The FDA does not have to do anything of the sort. They are paralyzed by their incompetence and can just keep delaying any type of decision. Dead money here.
    5 Feb 2014, 04:19 PM Reply Like
  • Mongoose7916
    , contributor
    Comments (230) | Send Message
     
    Did you see the results of the trial? The FDA might make SRPT do a phase 3, but if the phase 3 results are anything like the phase 2 they will have to approve it. It might take another 2 years for approval but it will eventually get approved.
    5 Feb 2014, 04:46 PM Reply Like
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