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Why Is This Week Important for Hemispherx Biopharma’s Orphan Drug Ampligen ?

December 18, 2012

This Thursday, December 20, 2012, the Arthritis Advisory Committee Meeting is scheduled  to “discuss New Drug Application (NDA) 22151, rintatolimod injection (proposed trade name Ampligen) submitted by  Hemispherx Biopharma, Inc, for the treatment of patients with Chronic Fatigue Syndrome (CFS)”. There is no FDA approved treatment for CFS.

It has not been an easy development for Hemispherx Biopharm :

  1. At the end of 2009, receives a FDA complete response letter asking for additional trials
  2. Data published in 2010 shows that Ampligen causes patients with CFS to use less concomitant medications vs. placebo
  3. Stigma of CFS being a psychological  disease, resulting in forgetting the physiological side of the disease
  4. FDA PDUFA date is 02/02/13.

A fascinating article from, titled, “Ampligen: Patient’s Will Determine Approval” examines the history of the drug development, the history of the CFS community in relation to the CDC, and the role that patient advocacy will play in determining the outcome of the upcoming FDA Advisory Committee in 2 days.

References article titled, “Hemispherx’s Ampligen Returns From the Brink”

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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