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Chronic Fatigue Patients Receive FDA Decision For Ampligen

February 4, 2013

Hemispherx BioPharma, in a February 4, 2013 Press Release, states that the company received a Complete Response Letter (CRL) from the FDA declining to approve its New Drug Application (NDA) for Ampligen (Rintatolimod) for Chronic Fatigue Syndrome (CFS). The FDA said Hemispherx should “conduct at least 1 additional clinical trial, complete various nonclinical studies and perform a number of data analyses”. The FDA says that the “data does not provide sufficient information to determine whether the product is safe for use in CFS due to the limited size of the safety database and multiple discrepancies within the submitted data”. This is similar to the decision made by the FDA Arthritis Advisory Committee Meeting (AdComm) in December 2012 – not providing sufficient data.

Hemispherx BioPharma plans to ask for an end-of-review conference with the FDA as a step to submitting a formal appeal to the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research in reference to this decision.

The FDA AdComm in December 2012, decides in an 8-to-5 vote that Ampligen isn’t ready for approval. Per the AdComm, this vote was a result of Hemispherx BioPharma not providing sufficient data. The FDA isn’t required to follow the advice of the Advisory Committee, but usually does. Reference the Blog Post for the complete story.

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

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