) recently announced that the Committee for Medicinal Products for
Human Use (
) of the European Medicines Agency (EMA) rendered positive opinion
for two of its drugs.
First, the CHMP gave a positive opinion to update the label of
its marketed drug Gleevec for extended use of adjuvant treatment
for three years in patients with KIT (CD117)-positive
gastrointestinal stromal tumors (GIST) versus the standard one-year
treatment currently approved.
Secondly, the CHMP issued a positive opinion on Novartis'
pipeline candidate Signifor (SOM230) for the treatment of Cushing's
disease, for which no medicines are currently available in the
European Union (
The positive opinion on Gleevec was based on data from a large
phase III trial (n=400) which demonstrated that Gleevec led to
significant improvement in both recurrence-free survival and
overall survival after three years of adjuvant treatment in
patients with KIT (CD117)-positive GIST versus the standard
one-year treatment currently approved.
This is the first-ever study demonstrating the survival benefits
of longer-term treatment with Gleevec. Novartis is also seeking
approval for a Gleevec label update in the US and has been granted
priority review by the US Food & Drug Administration (FDA).
Besides GIST, Gleevec is currently marketed for the treatment of
Philadelphia chromosome-positive chronic myeloid leukemia
The Signifor positive opinion was based on data from a phase III
trial in which the candidate demonstrated significant efficacy in
reducing the level of urinary free cortisol (UFC). In the US,
Novartis filed a new drug application (NDA) in June 2011 for
Cushing's disease which was subsequently withdrawn due to some
problem in the chemistry, manufacturing and controls (
The NDA will be resubmitted following discussion with the FDA.
Other than Cushing's disease, Signifor is also being studied for
the treatment of acromegaly and carcinoid syndrome in phase III
Earlier this month, Novartis also announced that its drug
Lucentis has been approved in China for the treatment of wet
age-related macular degeneration (wet AMD). Lucentis is currently
marketed for wet AMD as well as visual impairment due to diabetic
macular edema (DME) and macular edema following retinal vein
occlusion (RVO) in many countries including the US and EU.
Novartis' diabetes drug, Galvus, was also launched in China
recently as an add-on to metformin, the standard of care.
Currently, we have a Neutral recommendation on Novartis. The
company carries a Zacks #3 Rank (Hold rating) in the short run.
Though pleased with Novartis' wide range of products and its
efforts to diversify further, as is evident by the acquisition of
eye-care company Alcon, we prefer to remain on the sidelines in the
long term due to the imminent patent cliff faced by the
NOVARTIS AG-ADR (
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