The European Commission (EC) recently approved Swiss
) Votubia to treat adults suffering from renal angiomyolipoma
associated with tuberous sclerosis complex (TSC). The drug can
now be used in patients who are at risk of complications such as
tumor size or the presence of an aneurysm or multiple or
bilateral tumors but at the same time who do not require
Novartis' Votubia enjoys orphan drug status in the EU for TSC.
With the European approval, Votubia became the first medical
treatment in this patient population in the EU. The European
regulatory body's decision did not come as a surprise, as in
September this year the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) had given
a positive opinion on Votubia.
The favorable recommendation was based on data from a phase
III study, EXIST-2, which showed that 42% of patients treated
with Votubia experienced a response in angiomyolipoma compared to
0% of patients on placebo.
We note that Votubia is currently approved as Afinitor in the
US for the treatment of patients suffering from renal
angiomyolipoma, which is associated with TSC and not requiring
immediate surgery. The drug is also approved in the US and EU for
the treatment of advanced renal cell carcinoma (kidney cancer)
after the failure of treatment with
) Sutent (sunitinib) or
Onyx Pharmaceuticals, Inc.
) Nexavar (sorafenib).
In July 2012, Novartis' Afinitor gained approval both in the
US and the EU for the treatment of HR+ HER2- advanced breast
cancer in combination with exemestane, after the failure of
treatment with Femara (letrozole) or
) Arimidex (anastrozole).
Afinitor grew 82% on a constant currency basis during the
third quarter of 2012. We expect the product's label expansion
will drive sales further.
Currently, we have a Neutral recommendation on Novartis.
Novartis carries a Zacks #3 Rank (Hold rating) in the short
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