''My sense is we have seen cosmetic changes in the data, nothing substantial. We find ourselves where we were last June - we want more data. I am not sure how I am supposed to change my judgment. I feel
squeezed.''
FDA Panel Rejects Chiron/Cephalon's ALS Drug Myotrophin
By Anita Womack
BETHESDA, Md. (Dow Jones)-- A Food and Drug Administration panel voted 6-3 to reject Chiron
Corp.'s (CHIR) and Cephalon Inc.'s (CEPH) new drug application for Myotrophin for the treatment of
Lou Gehrig's disease.
''We are as anxious as nearly everyone afflicted (by the disease) in the audience,'' said Dr. David A.
Drachman, professor of neurology at the University of Massachusetts Medical School. ''My sense is
we have seen cosmetic changes in the data, nothing substantial. We find ourselves where we were
last June - we want more data. I am not sure how I am supposed to change my judgment. I feel
squeezed.''
Members of the FDA's Peripheral and Central Nervous System Drug Advisory Committee unanimously
said the application had only one adequate and well-controlled clinical trial (Study 1200) which proved
efficacy of the drug. ''The data does not look robust,'' said panel chairman Dr. Sid Gilman, of the
University of Michigan Medical Center.
Meanwhile, Cephalon officials told the panel that more than $130 million had been spent studying
amyotrophic lateral sclerosis, and the company remained committed to doing additional studies,
providing they got approval first.
''There's no happiness in a decision like this,'' said analyst Ira Loss of HSBC Washington Analysis. He
added that he does not believe the drug is finished.
The agency is not bound by the panel's decision, but generally follows its lead. |
