EU Nod for Novartis' Votubia - Analyst Blog
November 13 2012 - 4:20AM
Zacks
The European Commission (EC)
recently approved Swiss pharmaceutical giant
Novartis’ (NVS) 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 immediate surgery.
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 Pfizer
Inc.’s (PFE) Sutent (sunitinib) or Onyx
Pharmaceuticals, Inc.’s (ONXX) 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
AstraZeneca’s (AZN) Arimidex (anastrozole).
Our Take
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 run.
ASTRAZENECA PLC (AZN): Free Stock Analysis Report
NOVARTIS AG-ADR (NVS): Free Stock Analysis Report
ONYX PHARMA INC (ONXX): Free Stock Analysis Report
PFIZER INC (PFE): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research
Onyx Pharmaceuticals, Inc. (MM) (NASDAQ:ONXX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Onyx Pharmaceuticals, Inc. (MM) (NASDAQ:ONXX)
Historical Stock Chart
From Jul 2023 to Jul 2024