Switzerland-based pharmaceutical company,
) recently announced that the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) gave a
positive opinion on Votubia (everolimus) for the treatment of
patients suffering from renal angiomyolipoma, associated with
tuberous sclerosis complex (TSC).
On approval, the drug can be used in patients who are at risk of
complications such as tumor size or in the presence of aneurysm or
multiple or bilateral tumors but at the same time who do not
require immediate surgery.
Novartis' Votubia enjoys orphan drug status in the EU for TSC.
EU approval would make Votubia the first non-surgical treatment
alternative for patients diagnosed with kidney tumors associated
According to data from National Institute of Neurological
Disorders and Stroke, kidney tumors, or renal angiomyolipomas, are
found to affect up to 80% of patients with TSC and the increase in
tumor size can be life-threatening.
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 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
Votubia is also approved as Afinitor 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).
We note that Novartis recorded Afinitor sales of $175 million in
the second quarter of 2012.
Currently, we have a Neutral recommendation on Novartis. The
company carries a Zacks #3 Rank (Hold rating) in the short run.
ASTRAZENECA PLC (AZN): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
ONYX PHARMA INC (ONXX): Free Stock Analysis
PFIZER INC (PFE): Free Stock Analysis Report
To read this article on Zacks.com click here.