Ampligen Will Be Early Test Of FDA Consolidation Of Chronic Fatigue Drug Reviews
FDA’s decision to consolidate oversight for chronic fatigue syndrome treatments in the Division of Pulmonary, Allergy and Rheumatology Products will face an early test with Hemispherx Biopharma Inc.’s expected submission of an amended NDA for its investigational agent Ampligen in the third quarter.
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December’s Arthritis Advisory Committee review of Hemispherx’s drug provided FDA with the first public opportunity to explain in detail why the chronic fatigue syndrome drug, in development for almost 25 years, has not passed regulatory muster to date.
In review documents released ahead of a Dec. 20 advisory committee meeting, agency questions the validity of Hemispherx’s post-hoc efficacy analyses and raises concerns about adverse events and the reliability of the safety data.
Ampligen has a shot at becoming the first drug approved for chronic fatigue syndrome, with an advisory panel tentatively slated for Dec. 20. FDA recently unveiled plans to encourage drug development for this condition.