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  • on 01.12.2009
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Hemispherx gets FDA Complete Response Letter on Ampligen NDA

Dec1

2 December 2009 – US-based specialty pharmaceutical company Hemispherx Biopharma Inc (AMEX: HEB) said yesterday it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) regarding the Ampligen New Drug Application (NDA) for chronic fatigue syndrome.
In accordance with its 2008 "Complete Response" procedure, the FDA reviewers determined that they cannot approve the application in its present form and provided specific recommendations to address the outstanding issues. Hemispherx said it is reviewing the CRL and will seek an expedited meeting with the agency to discuss its recommendations.
The FDA stated that the two primary clinical studies submitted with the NDA did not provide credible evidence of efficacy of Ampligen and recommends at least one additional clinical study which shows a convincing effect and confirms safety in the target population. The agency indicated that the additional study should be of sufficient size and sufficient duration (6 months) and include appropriate monitoring to rule out the generation of autoimmune disease. In addition, patients in the study should be on more than one dose regimen, including at least 300 patients on dose regimens intended for marketing. Finally, the additional study must incorporate both a well-controlled QT interval study and pharmacokinetic evaluations.
Other items required by the FDA include certain aspects of Non-Clinical safety assessment, and Product Quality. In the Non-Clinical area, the FDA is recommending that the company complete rodent carcinogenicity studies in two species. As part of the NDA submission, the company had requested that these studies be waived, but the waiver has not been granted. Certain additional non-clinical studies and additional data to support non-clinical studies already submitted with the NDA are also recommended by the FDA. Prior to the receipt of the CRL, the company had already begun many of these additional studies and the collection of the requested additional data.
Under the Product Quality section of the CRL, the FDA recommends that the company submit additional data and complete various analytical procedures. The collection of these data and the completion of these procedures is already part of the company’s ongoing Quality Control, Quality Assurance programme for Ampligen manufacturing under cGMP (current Good Manufacturing Practice Guidelines) and the manufacturing enhancement programme recently undertaken by the company and announced in a news release on 16 September 2009.
Finally, the FDA commented on Ampligen manufacturing noting the need to resolve outstanding inspection issues at the facilities producing Ampligen. These include the company facility located in New Brunswick, NJ and one of the company’s third party manufacturing facilities (Hollister-Stier Laboratories).
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(c) 2009 M2 COMMUNICATIONS

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