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MORE) DOW JONES NEWS 05-12-98
06:23 PM
FDA Cephalon -2-: Steps Needed For Lou Gehrig's Disease Drug
WASHINGTON (Dow Jones)--The U.S. Food and Drug Administration issued an
approvable letter to Cephalon Inc. (CEPH) and Chiron Corp. (CHIR) Tuesday for
their drug Myotrophin, designed to treat Lou Gehrig's disease.
An approvable letter outlines what steps the FDA wants a company to take before it
will clear a drug for marketing.
Myotrophin will be Cephalon's first drug on the market, but it wasn't a shoo-in. FDA
expert panels weren't convinced the drug was effective in prolonging lives of patients
with the incurable central nervous system disorder, officially called amyotrophic lateral
sclerosis. The disease attacks nerves in the brain and spinal cord, which leads to
paralysis and death.
A clinical trial of the drug, conducted in the U.S., showed it prolonged some patients'
lives up to three months. However, another study, in Europe, didn't show any benefit
to patients using the drug.
The conflicting studies led an FDA advisory panel to recommend against approving the
drug in May 1997. In 1996, the same panel urged the companies to conduct a
tie-breaking study, but the companies instead resubmitted the same two studies with a
different analysis of the data.
Another panel review, scheduled for last month, was canceled after the FDA said it
needed more time to study the drug and its data.
Lou Gehrig's disease, named for the famous baseball player who died from it, affects
about 30,000 Americans.
-Otesa Middleton; 202-862-6654
(END) DOW JONES NEWS 05-12-98
06:52 PM
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