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March 6, 2007: Tekturna, the new
hypertension (high BP) drug from Novartis AG, will
be released in US markets this month. The company
today won FDA approval for Tekturna, a new class
of anti-hypertension medicines currently led by
Diovan from Novartis. According to American heart
Association, there are 60 million high BP patients
in the US, for whom Tekturna will be a boon.
Tekturna will be sold in two dosages of 150 mg and
300 mg. The drug was submitted to the European
authorities for review last year.
There was a three-month delay by the FDA in
approving Tekturna, during which the agency more
clinical trial data from the company.
Tekturna will be released in US later this month,
which will be the first market for the anti-hyper
tension drug.
Another Novartis drug, Diovan is currently used
for treating high blood pressure. The patent for
this drug expires in 2012. Tekturna is believed to
be more effective than Diovan.
Reacting to the news of Tekturna approval, shares
of Novartis AG rose nearly 4%. Analysts have given
an outperform rating to the Novartis stock, since
the Tekturna approval is seen as an indication
that Novartis can manufacture and market
cutting-edge drugs.
Tekturna will be known as Rasilez outside the
United States. It belongs to a category of drugs
called renin inhibitors. According to estimates,
Tekturna and Rasilez may together bring in sales
worth $3.6 billion for Novartis by 2016. Tekturna
approval may also lead to the company raising its
earnings forecasts, analysts said. Tekturna works
by targetting renin in the human system, which
triggers an enzyme which contributes to high blood
pressure.
Tekturna is pegged as a superior drug, since the
blood pressure does not show signs of bouncing
back after the treatment is over. Also, the onset
of action by Tekturna is immediate.
Hypertension is believed to be present in one
billion people worldwide, with nearly 70% unable
to control it. The Tekturna medicine, orally
administered, need to be taken once daily. High
blood pressure is believed to be one of the most
important reasons for cardiac arrest. In tests,
Tekturna was found to provide significant relief
in hypertension patients in 24 hours. The tests
were conducted among 6400 patients. Tekturna
provided efficacy when used along with other blood
pressure reducing formulations. Among the few side
effects of Tekturna are diarrhoea, cough and
rashes. It is also not advisable to be used during
pregnancy. Those who plan to become pregnant are
also advised to consult their doctor before
embarking on Tekturna medication. Rarely,
angioedema has been reported. The drug was
developed in association with Speedel.
BY OUR PHARMA CORRESPONDENT
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