Cephalon Sticks To Myotrophin Plan

Afinal US marketing approval application for Myotrophin (recombinant human insulin-like growth factor-1; somatomedin C) will be filed as planned by the end of this year, said the product's developer, Cephalon Inc, "whose strategy is to get the best down there as soon as we can," Cephalon chief executive Frank Baldino told a Carson Group and BioCentury Publications conference, reported by Reuters.

In June, a US Food and Drug Administration advisory panel unanimously approved an early access program for Myotrophin (used to treat amyotrophic lateral sclerosis, or Lou Gehrig's disease; Marketletter June 17), though some panel members said they would like to see another trial. That led to doubts among investors as to whether the FDA would require a fresh trial ahead of final approval, which would significantly delay launch. Mr Baldino said Cephalon wants to run a study of Myotrophin in combination with the only FDA-approved ALS drug, Rhone-Poulenc Rorer's Rilutek (riluzole).