) recently announced that the Committee for Medicinal Products for
Human Use (
) of the European Medicines Agency (EMA) has recommended including
a warning in the label of hypertension medicine Rasilez in the
European Union (
). Rasilez is marketed as Tekturna in the US.
In December 2011 Novartis had stopped the ALTITUDE study which
was investigating Tekturna/Rasilez in a high-risk population of
patients with type-II diabetes and renal impairment following
recommendation from a Data Monitoring Committee.
Following discussions between CHMP and Novartis, the former
recommended that the label of Rasilez and its combination products
be updated to include contradictions in using Rasilez in
combination with other hypertension medicines known as angiotensin
converting enzyme (
) inhibitor or angiotensin receptor blocker (
) in patients with diabetes or moderate-to-severe renal
The CHMP has also requested that a warning be included to
recommend against using Rasilez and its combination products in
patients who are already taking an ACE inhibitor or an ARB.
Novartis has begun work to revise the EU label accordingly.
Following termination of the ALTITUDE study in December 2011,
Novartis recommended against use of Rasilez/Tekturna-based products
in combination with an ACE inhibitor or ARB in hypertensive
patients with diabetes. It ceased promotion of any such combination
The recommendation holds good in all countries outside EU as
Novartis continues to interact with health authorities to resolve
the issue and determine its implications. In 2012, Novartis has
forecast Tekturna/Rasilez sales to be reduced to half of what they
were in 2011.
Currently, we have a Neutral recommendation on Novartis. The
company carries a Zacks #4 Rank ("Sell" rating) in the short run.
Though pleased with Novartis' wide range of products and its
efforts to diversify further, we prefer to remain on the sidelines
in the long term due to the imminent patent cliff faced by the
NOVARTIS AG-ADR (
): Free Stock Analysis Report
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