21 December 2012: http://www.nasdaq.com/article/fda-a...-fatigue-syndrome-20121221-00738#.UNWIYKya_To
PHILADELPHIA, Dec. 21, 2012 (GLOBE NEWSWIRE) --
Hemispherx Biopharma, Inc.(NYSE MKT:
HEB) (the "Company" or "Hemispherx") today announced the outcome of the meeting of the Arthritis Advisory Committee (the "AAC") of the U.S. Food and Drug Administration (the "FDA") on the New Drug Application ("NDA") for Ampligen® for Chronic Fatigue Syndrome ("CFS").
On the question: "Considering the totality of the data, is there substantial evidence of efficacy for Ampligen for the treatment of patients with chronic fatigue syndrome (CFS)?," the AAC voted 9 no, 4 yes and 1 AAC member left the room and did not vote.
On the question: "Has the safety of Ampligen been adequately assessed and characterized for the treatment of chronic fatigue syndrome (CFS)?," the AAC voted 9 no, 4 yes and 1 AAC member left the room and did not vote.
On the question: "Is the safety profile of Ampligen adequate for approval for the treatment of CFS?," the AAC voted 8 yes, 5 no and 1 non-vote.
On the question: "Based on the information included in the briefing materials and presentations, has the applicant provided sufficient efficacy and safety data to support marketing of Ampligen for the treatment of CFS?," the AAC voted 8 no, 5 yes and 1 non-vote.
Hemispherx is committed to the Ampligen® clinical development program and to bringing Ampligen® to market to ease the suffering of those seriously afflicted with CFS. The Company will also continue to work closely with the FDA to support the review of this investigational compound. Hemispherx will seek to do everything necessary to confirm in a scientifically rigorous manner that Ampligen® is a safe and effective treatment for CFS.
The AAC based its voting on a review of data from the Ampligen®clinical development program included as part of the Company's NDA submission. This submission included data on nine studies conducted in patients with CFS, including two pivotal studies and seven supportive studies. The trials were designed to evaluate safety, tolerability and efficacy in the approximately 845 patients (589 unique subjects suffering from severely debilitating CFS) who received Ampligen®.
The majority of the AAC members expressed the view that an additional controlled clinical trial of Ampligen should be conducted prior to the FDA granting approval.
The Prescription Drug User Fee Act ("PDUFA") review goal for the FDA to complete its review of the NDA is February 2, 2013.
The FDA uses committees, like the AAC, to obtain independent expert advice on scientific, technical, and policy matters to assist in its mission to protect and promote public health.
The FDA is not bound by the AAC's recommendation, but will consider their recommendation in its review.
DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking" statements (explained below), including statements about the remaining steps to potentially gain FDA approval of the Ampligen® NDA for the treatment of Chronic Fatigue Syndrome.
The final results of these and other ongoing activities could vary materially from Hemispherx's expectations and could adversely affect the chances for approval of the Ampligen® NDA.
These activities and the ultimate outcomes are subject to a variety of risks and uncertainties, including but not limited to risks that (i) the FDA may follow the AAC's recommendation and decide not to approve the Ampligen® NDA; (ii) the FDA may ask for additional data, information or studies to be completed or provided prior to approval; (iii) the FDA may require additional work related to the commercial manufacturing process to be completed prior to approval or may, in the course of the inspection of manufacturing facilities, identify issues to be resolved; (iv) the FDA may determine that the complete response submitted by Hemispherx is not "complete," potentially requiring the Company to conduct additional activities before it can re-file, if at all, the complete response; and (v) until completion of the FDA review of the Ampligen® NDA and final approval of the product and prescribing information, if any, the specific patient population for which Ampligen® may be indicated will not be known. Any failure to satisfy the FDA's requirements could significantly delay, or preclude outright, approval of the Ampligen® NDA.
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