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Chronic Fatigue Syndrome Patients Waiting For Ampligen FDA Decision

February 3, 2013
Generic Name Trade Name Sponsor Indication PDUFA Date
Rintatolimod Ampligen Hemispherx BioPharma Chronic Fatigue   Syndrome (CFS) 2/02/13

February 2, 2013, is the scheduled FDA PDUFA date for Hemispherx BioPharma’s orphan drug Ampligen (Rintatolimod) for Chronic Fatigue Syndrome (CFS). The date has come and passed. The FDA usually publishes a Press Release when a drug is approved, like it did for orphan drugs Kynamro and Ravicti last week. Since February 2, 2012, is a Saturday, some investors expected a FDA announcement this past Friday, February 1. If Ampligen isn’t approved of, then the FDA notifies Hemispherx BioPharma in a non-public letter. It is up to the company how this non-approval is communicated to the public and shareholders. So either the FDA is waiting until business day, Monday, February 4, to announce its decision OR a non-approval decision has already been made and Hemispherx BioPharma hasn’t made it public yet.

 CFS advocate Robert Miller begins a hunger strike on January 29, 2013, that he says will continue until patients have access to Ampligen.

The FDA Arthritis Advisory Committee (AdComm) Meeting in December 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 AdComm, the issue with Ampligen is whether or not the drug is effective and safe. The FDA says there was missing data in the clinical trials that made it difficult to determine if Ampligen is safe. The question is raised as to whether the data meet “drug approval requirements demonstrating substantial evidence of safety and efficacy, or effectiveness”. Also, the Committee questions the clinical trial results based on a small number of patients. In conclusion, the Committee determines that Ampligen may work in a small group of CFS patients, but it is not shown clearly in the resulting data results.

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

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