Myotrophin: What's different this time

Cephalon Inc.'s Myotrophin insulin-like growth factor-1 will face its third FDA advisory panel on April 9, and a few things have changed since the company's appearances in 1996 and 1997. The FDA has additional data in hand; the composition of the panel has changed; and newly implemented fast-track regulations resulting from FDA reform provide a potentially face-saving way out of the agency's desire for more data and the company's refusal to run another study prior to approval.

Despite political and public pressure, an FDA panel in May 1997 refused to recommend approval of the product to treat amyotrophic lateral sclerosis (ALS) on the strength of the data provided, saying it needed to see a confirmatory trial...