) recently announced that the US Food and Drug Administration
(FDA) has approved Exjade (deferasirox) for the treatment of
chronic iron overload in patients aged ten years and
These patients are detected with non-transfusion-dependent
thalassemia (NTDT) syndrome along with a liver iron concentration
of at least 5 mg of iron per gram dry weight and a serum ferritin
measurement more than 300 micrograms per liter.
Approval was based on results from the THALASSA study which
showed that the iron burden was significantly reduced in patients
treated with Exjade compared with those treated with placebo.
Following the approval, Exjade becomes the first drug to be
approved in the US for treating patients suffering from these
forms of thalassemia.
We remind investors that Exjade was approved in the EU in Dec
2012 for the treatment of chronic iron overload requiring
chelation therapy when treatment with deferoxamine is
contraindicated or is inadequate in patients aged 10 years and
above, who have been suffering from NTDT syndromes.
With this approval, Exjade becomes the first oral treatment to
be approved in the EU for the treatment of chronic iron overload
in patients suffering from NTDT syndromes.
Meanwhile, regulatory filings are in progress for Exjade as a
treatment of chronic iron overload in patients with NTDT
syndromes. First approved in 2005, Exjade is now approved in more
than 100 countries, including the US, EU and Japan.
We note that Exjade generated sales of $870 million in 2012,
up 7% year over year, driven by growth in Europe, Latin America,
Canada and Japan. However, the drug did not fare well in the
Currently, Novartis carries a Zacks Rank #3 (Hold). Large-cap
pharma companies that currently look better-positioned include
). All three are Zacks Rank #2 (Buy) stocks.
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