FDA Approves Limited Use of Iplex in ALS
 

FDA Approves Limited Use of Iplex in ALS

By John Gever, Senior Editor, MedPage Today
Published: March 11, 2009


ROCKVILLE, Md., March 11 -- The FDA has decided to allow a few patients with amyotrophic lateral sclerosis (ALS) access to mecasermin rinfabate (Iplex) under "compassionate use" rules.

However, with supplies of the drug extremely limited, access will be restricted to patients who have already filed requests. The FDA wants to reserve the remaining stock for a controlled clinical trial promised by the drug's manufacturer, Insmed.


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