Monday, November 6, 1995
Since June, when data from pivotal trials of Cephalon Inc.'s Myotrophin IGF-1 and Rhone-Poulenc Rorer's Rilutek (riluzole) first enabled comparisons between the two drugs, Wall Street gradually has come to the conclusion that Myotrophin will be the commercial winner in the amyotrophic lateral sclerosis market.
That conclusion was enhanced by the presentation of data at RPR's FDA advisory panel meeting, at which the panel narrowly endorsed approval of the drug (see BioCentury Extra, Sept. 19). At the meeting, the FDA, the advisory committee, RPR and ALS advocates all agreed that the benefits of the drug are marginal, with a three-month survival benefit and no discernible improvement in the quality of life.
CEPH, meanwhile, has presented data from two trials showing improved quality of life, and a post hoc analysis of one trial has shown a six month survival benefit at 18 months (see BioCentury Extras, June 12 and 13, and Nov. 1).
But while Wall Street's attitude has solidified in the past five months, clinicians still appear to be taking a wait-and-see attitude. When BioCentury first asked clinicians to rate the two drugs in June, they expressed no consensus. Rather, they said they couldn't tell what the results would mean in clinical practice, particularly since the trials weren't comparable (see BioCentury, June 19).