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Did The FDA Advisory Committee Approve of Hemispherx BioPharma’s Orphan Drug Ampligen For Chronic Fatigue Syndrome ?

December 21, 2012

    The FDA Arthritis Advisory Committee Meeting on December 20, 2012, decides in an 8-to-5 vote that Hemispherx BioPharma’s orphan drug Ampligen (Rintatolimod) for the treatment of Chronic Fatigue Syndrome (CFS) isn’t ready for approval. Per the Committee, this vote was a result from the company not providing sufficient data.  About 36 patients and family members testified in person or via video, urging the approval of Ampligen.   

     Per the Committee, the issue with Ampligen is whether or not the drug is effective and safe. The FDA said there was missing data in the clinical trials that made it difficult to determine if Ampligen is safe. The question was raised as to whether the data meet “drug approval requirements demonstrating substantial evidence of safety and efficacy, or effectiveness”.  Also, the Committee questioned the clinical trial results based on a small number of patients. In conclusion, the Committee determined that Hemispherx BioPharma’s Ampligen may work in a small group of CFS patients, but it was not shown clearly in the resulting data results.

    The FDA expects to make a decision on Ampligen for CFS by the PDUFA date of February 2, 2012. The FDA isn’t required to follow the advice of the Advisory Committee, but usually does.

References

Benzinga.com December 20, 2012 article titled, “Hemispherx BioPharma Soars Then Plunges as FDA Panel Votes Against Ampligen Approval”

MedPageToday.com December 20, 2012 article titled, “FDA Panel Nixes Hemispherx CFS Drug”

****   The Wall Street Journal December 20, 2012 article titled, “Panel Rejects Drug for Chronic Fatigue Syndrome”.

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

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