Manufacturer says US authorities will review use of Ampligen for Chronic Fatigue Syndrome | Nasdaq report | 24 September 2012

September 25, 2012

The US-based Nasdaq stock exchange reported this yesterday (24 September 2012).

Hemispherx Biopharma Says FDA Will Review Ampligen For Chronic Fatigue Syndrome

( – Hemispherx Biopharma Inc. (HEB) said that the U.S. Food and Drug Administration or “FDA” has tentatively scheduled an Advisory Committee meeting to discuss the Ampligen New Drug Application for Chronic Fatigue Syndrome or “CFS”, which is currently under review by the FDA. The date of the Advisory Committee review has been tentatively scheduled for December 20, 2012. The Prescription Drug User Fee Act review goal for the FDA to complete its review is February 2, 2013.

Recently, the FDA has become increasingly active in working with the CFS and Myalgic Encephalomyelitis communities. On September 13, 2012, a teleconference was held between the FDA, patients, advocacy organizations and other stakeholders. As the FDA explained during that teleconference, it plans to host an “Excellency in Advocacy” webinar in mid-November 2012 that is intended to “advise patient advocates or advocacy groups on how to come together and develop common themes to ultimately further [their] mutual goals and be beneficial to everyone.”

During the Spring of 2013, the FDA intends to hold a workshop “to explore a multitude of scientific issues about identifying valid, reliable and measurable outcomes to determine if disease symptoms improve with intervention.”

In the September 13 teleconference, Sandra Kweder, M.D., Deputy Director, CDER Office of New Drugs stated that the FDA considers CFS/ME to be a “serious and life threatening condition” and that the FDA is “committed to making promising drugs available to individuals with serious diseases as quickly as possible for the rapid development and review of these types of therapy.” Also, Hemispherx anticipates that the FDA's recently expanded statutory authority under the Food and Drug Administration Safety and Innovation Act may be relevant to the potential for approval of Ampligen, though there can be no assurance how the FDA will implement the new FDASIA provisions.

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