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FDA rejects Hemispherx's chronic fatigue drug Ampligen
Friday 4 December 2009
FDA rejects Hemispherx’s chronic fatigue drug Ampligen
Philadelphia Business Journal - by John George Staff Writer
The Food and Drug Administration has rejected Hemispherx BioPharma’s new drug application for Ampligen, an experimental treatment for chronic fatigue syndrome that the biotechnology company has spent more than three decades developing and testing.
Hemispherx’s stock plunged more than 42 percent Wednesday morning to 68 cents a share from Tuesday’s close of $1.20 per share.
Late Tuesday, the FDA told Philadelphia-based Hemispherx (AMEX:HEB) that two primary clinical studies submitted by the company “did not provide credible evidence of efficacy of Ampligen.” The agency is recommending Hemispherx conduct at least one additional clinical study, involving a minimum of 300 patients taking the drug for six months, “which shows convincing effect and confirms safety in the target population.”
Hemispherx officials said they are reviewing the FDA’s complete response letter and will seek an expedited meeting with the agency to discuss its recommendations.
In a statement, Hemispherx announced “management is pleased to have received specific advice on the remaining issues and is looking forward to making a thorough but expedited response its top priority, and plans to take all appropriate steps to seek approval and commercialization of Ampligen.”
The FDA also raised questions about product quality, manufacturing issues at the company’s New Brunswick, N.J., plant, and the company’s nonclinical safety assessment. The agency is also recommending Hemispherx complete rodent carcinogenicity studies in two species.
The article originally appeared here.
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