Ampligen NDA review sailing ahead
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Hemispherx Biopharma expects to be in final discussions with FDA about its Ampligen NDA for treatment of chronic fatigue syndrome by the end of this year or the start of 2009, CEO William Carter tells investors July 17. Though the firm received a standard review for the toll-like receptor 3 agonist, the process "turns out to be fast tracking," with about seven months to go before the product's Feb. 25 user fee date. "We frankly couldn't go any faster than the schedule we have," Carter says. The biopharma expects to answer the agency's remaining questions by the end of September. It is also looking into Ampligen as a potential MAO enhancer for treatment of cancer, specifically ovarian and prostate. Hemispherx submitted the NDA for chronic fatigue syndrome in October, supported by data from four pivotal trials (1Pharmaceutical Approvals Monthly April 2008)