FDA Orders Halt to Trial of Novartis's Zolgensma
October 30 2019 - 3:02AM
Dow Jones News
By Carlo Martuscelli
The U.S. Food and Drug Administration has ordered an ongoing
clinical trial of Novartis's Zolgensma halted after adverse
findings were detected in an animal study.
The stop concerns a clinical trial called Strong which is
examining Zolgensma administered through an injection in the spinal
column.
Novartis said Wednesday that the regulator asked it to pause the
trial after the company reported nerve-cell inflammation, sometimes
accompanied by cell degeneration, in animals.
The order has no impact on the already-approved, intravenous
formulation of the gene therapy for spinal muscular atrophy, which
continues to be available for patients in the U.S., the
pharmaceutical company said.
The injection formulation of Zolgensma is being studied as a
treatment for patients up to the age of five. The currently
approved formulation can only be given to newborns and toddlers up
to the age of two.
The company earlier this year discovered that data on mouse
testing related to the manufacture of certain lots of Zolgensma had
been manipulated by scientists. The FDA criticized Novartis for
failing to disclose those concerns immediately, but said the
manipulation didn't change its view that Zolgensma is safe and
effective.
Despite the data manipulation scandal, sales of what is the
world's most expensive drug were healthy in its first full quarter
in the market, totaling around $160 million.
Write to Carlo Martuscelli at carlo.martuscelli@dowjones.com;
@carlomartu
(END) Dow Jones Newswires
October 30, 2019 02:47 ET (06:47 GMT)
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