Hemispherx Ampligen NDA incomplete
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA has notified Hemispherx Biopharma that its NDA submission for Ampligen (PolyI:polyC12 U) for chronic fatigue syndrome "has been determined to be insufficiently complete to permit a substantive review" based on the agency's preliminary review, the firm announces Dec. 7. Eleven deficiencies were cited in the clinical section and three in the preclinical section; there were no deficiencies in the chemistry, manufacturing and controls section. Hemispherx speculates that several factors may "influence the pace of the regulatory path": the drug has a long regulatory history (roughly 20 years), the drug is first-in-class, and clinical data reporting guidelines have changed since the initial Ampligen studies were conducted in the late 1980s and early 1990s. The company intends to respond promptly in writing and will request a guidance meeting to clarify outstanding items...