FDA Approves Novartis’ Exjade (BAYRY) (LLY) (NVO) (NVS)

Novartis (NVS) 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 above.

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 US.

Currently, Novartis carries a Zacks Rank #3 (Hold). Large-cap pharma companies that currently look better-positioned include Eli Lilly (LLY), Bayer (BAYRY) and Novo Nordisk (NVO). All three are Zacks Rank #2 (Buy) stocks.