FDA OKs Novartis Vaccine Against Seasonal Flu In Fast Review
DOW JONES NEWSWIRES
The Food and Drug Administration approved a new Novartis AG (NVS, NOVN.VX) flu
vaccine, Agriflu, in an accelerated process Friday.
The vaccine to prevent disease caused by influenza virus subtypes A and B is
for people age 18 and older. It does not prevent the H1N1 virus, also known as
swine flu.
The Swiss drug maker produces Agriflu in Siena, Italy. But the company on
Tuesday opened a vaccine-manufacturing plant in North Carolina designed to make
flu vaccines without relying on decades-old technology that employs millions of
chicken eggs to grow viruses.
Agriflu is administered as a single injection in the upper arm and is
available in single dose, pre-filled syringes that do not contain preservatives.
The approval "is an important step in adding to the production capacity to
enhance the supply of vaccine for the United States for future influenza
seasons," said Karen Midthun, acting director of the FDA's Center for Biologics
Evaluation and Research.
As part of the accelerated approval process, Novartis is required to conduct
more studies to verify the vaccine induces levels of antibodies in the blood
that are effective in preventing seasonal influenza.
The company makes another licensed seasonal flu vaccine, Fluvirin, for use in
the U.S. Fluvirin is approved for people age 4 and older.
Earlier this year, a Novartis executive said the company is hoping the recent
flu pandemic will raise awareness of the need for preparedness and will result
in higher and more steady demand for its seasonal flu vaccines.
Novartis has been losing money on its flu vaccine production every year since
it acquired the business in 2006. But this year, demand for Novartis' flu
vaccines has outstripped production capacity. The emergence of the first flu
pandemic in more than 40 years resulted in big orders from governments that want
to protect their citizens from the illness.
Previously, low profitability had led to a slump in production, with many
pharmaceutical companies giving up on making flu vaccines toward the end of the
last century.
Novartis's shares slid 0.9% to $54.90 in after-hours trading. The stock has
gained nearly one-quarter in the past year.
-By Kathy Shwiff, Dow Jones Newswires; 212-416-2357; Kathy.Shwiff@dowjones.com
(END) Dow Jones Newswires
11-27-091620ET
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