Latest Health research news from the around the globe: Novartis receives FDA approval for Valturna®, a single-pill combination of valsartan and aliskiren, to treat high blood pressure 

Novartis receives FDA approval for Valturna®, a single-pill combination of
valsartan and aliskiren, to treat high blood pressure
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admin on 19 September, 2009 02:33:00
 
Basel, - The US Food and Drug Administration (FDA) has approved Valturna(R)
(aliskiren and valsartan) tablets, the first and only medicine to target two key
points within the renin system, also known as the renin angiotensin aldosterone
system (RAAS), an important regulator of blood pressure[2]. This is the first
approval for Valturna, which is indicated for the treatment of high blood
pressure in patients not adequately controlled on aliskiren or angiotensin
receptor blocker (ARB) monotherapy and as initial therapy in patients likely to
need multiple drugs to achieve their blood pressure goals[1]. "This unique
combination brings together the powerful blood pressure lowering effects of
valsartan and aliskiren," said Joe Jimenez, CEO of the Novartis Pharmaceuticals
Division. "It offers an important additional treatment option for physicians and
hypertension patients, many of whom are not at their blood pressure goal.
Valturna builds upon our strong cardiovascular franchise and is consistent with
our long-term commitment to developing effective and innovative therapies. It
further strengthens our growing portfolio of single-pill combinations to treat
high blood pressure." Valturna combines in a single pill valsartan, the active
ingredient in Diovan(R), the number one selling blood pressure medication
worldwide[3], and aliskiren, the active ingredient in Tekturna(R), the only
approved direct renin inhibitor (DRI). Valturna offers significantly greater
blood pressure reduction than either valsartan or aliskiren alone[1]."When it
comes to diagnosing and treating high blood pressure, there is a real need for
innovative therapies that help patients get to a healthier blood pressure
range," said John Flack, M.D., Valturna investigator, and Chairman of the
Department of Internal Medicine, Wayne State University, Detroit. "Now for the
first time, we have a treatment option in one pill that targets two key points
of the RAAS, which may be overactive in many hypertensive patients." This
approval was primarily based on a pivotal eight-week randomized, double-blind,
placebo-controlled clinical trial in approximately 1,800 patients, which studied
aliskiren 150 mg and 300 mg and valsartan 160 mg and 320 mg alone and in
combination. The initial doses of aliskiren and valsartan were 150 mg and 160
mg, respectively, and were increased at four weeks to 300 mg and 320 mg,
respectively. Blood pressure reductions with the aliskiren/valsartan combination
were significantly greater than with the monotherapies or placebo at the 8-week
primary endpoint. Mean systolic and diastolic blood pressure reductions from
baseline were 17.2/12.2 mmHg for aliskiren 300 mg/valsartan 320 mg, compared
with 12.8/9.7 mmHg for valsartan 320 mg, 13.0/9.0 mmHg for aliskiren 300 mg, and
4.6/4.1 mmHg for placebo (p