Market Wire - FDA Approves Higher Dose Formulations of Diovan HCT(R) (Valsartan/Hydrochlorothiazide) for Treatment of High Blood Pressure
The U.S. Food and Drug Administration
(FDA) approved two new, higher dose formulations of the high blood pressure
medication Diovan HCT (valsartan/hydrochlorothiazide): 320/12.5 mg and
320/25 mg. The approval of the higher strengths of Diovan HCT provides
more options to help physicians more effectively manage their patients’
high blood pressure. The new formulations of Diovan HCT will be
commercially available by early June 2006.
Diovan HCT is a combination of the efficacious blood pressure medicine
Diovan (valsartan), the most prescribed agent in the ARB (angiotensin
receptor blocker) class, and the diuretic hydrochlorothiazide (HCTZ). The
majority of high blood pressure patients will require a combination of two
therapies, like Diovan HCT, to achieve blood pressure goals. Diovan HCT
provides greater blood pressure-lowering benefits to patients who require
more than either the diuretic or Diovan alone. Previously, Diovan HCT was
available in 80/12.5 mg, 160/12.5 mg, and 160/25 mg tablets.
“Millions of patients already rely on Diovan and Diovan HCT to help them
get to goal and maintain healthier blood pressure levels,” said Alex
Gorsky, head of pharma, North America and chief executive officer, Novartis
Pharmaceuticals Corporation. “The approval and availability of these new
formulations means that, with Diovan HCT, physicians will have the widest
and most flexible range of dosing options in the ARB class.”
High blood pressure is a public health crisis, affecting more than 65
million Americans or one in three adults. The risk of cardiovascular
disease doubles with every increase of 20/10 mmHg above a healthy blood
pressure of 115/75 mmHg. High blood pressure medications not only lower
blood pressure, but also reduce the risk of suffering a stroke or heart
attack. Overall 70 percent of people with high blood pressure do not have
their condition controlled. Moreover, about half of those taking medication
for their condition do not have it successfully managed, underscoring the
need for more powerful treatments.
Details of Data Supporting Approval
Data supporting approval showed the new higher doses of Diovan HCT provided
significantly greater reductions in blood pressure compared to either
therapy alone. Diovan HCT 320/25 mg lowered systolic/diastolic blood
pressure 25/17 mmHg compared to 6/7 mmHg with placebo alone.
The blood-pressure lowering effect of the high doses of Diovan HCT was
maintained throughout long-term follow-up studies lasting up to one year
(without placebo control), and was the same regardless of age or gender,
and for black and non-black patients.
The overall incidence of adverse events with Diovan HCT was comparable to
placebo. Further, giving Diovan in combination with HCTZ lowered the
incidence of hypokalemia (low blood potassium) associated with HCTZ.
Hypokalemia can cause cardiac arrhythmia, muscle pain and/or weakness,
general discomfort, irritability, extreme thirst, frequent urination and
confusion.
Data To Be Presented At ASH
Much of the data supporting approval of the higher dose formulations of
Diovan HCT will be presented at the upcoming American Society of
Hypertension, Inc. (ASH) Annual Scientific Meeting and Exposition May
16-20, 2006, in New York, NY. In total, more than 30 studies related to
Diovan, Diovan HCT and other Novartis medications for treating high blood
pressure will be presented. The presentations will include clinical data
on the efficacy of Rasilez (aliskiren) and Exforge (amlodipine
besylate/valsartan), both investigational agents for which Novartis
recently submitted new drug applications to the FDA for their use in
treating high blood pressure.
“The breadth and depth of data to be presented at ASH underscore Novartis’
innovation and leadership in the hypertension category,” Mr. Gorsky added.
“We continue to strongly support a robust research program to fully develop
Diovan and Diovan HCT, as well as investigate new therapies such as Rasilez
and Exforge.”
About Diovan and Diovan HCT
Diovan and Diovan HCT should be discontinued as soon as pregnancy is
detected because it may cause harm or even death to the unborn child. If
you get pregnant or plan to get pregnant, call your doctor right away.
Do not take Diovan or Diovan HCT if you are allergic to any of the
ingredients in these products.
Do not take Diovan HCT if you have a history of reduced urine output, or
have allergic reactions to certain drugs known as sulfonamides. If you’re
taking Diovan HCT, tell your doctor about all your medical conditions and
medicines you take, including: liver or kidney problems, lupus or if you
take lithium.
In clinical studies with Diovan and Diovan HCT, side effects have generally
been mild. The most serious side effects with both Diovan and Diovan HCT
are low blood pressure (hypotension) and kidney problems, and additionally
with Diovan HCT, skin rash. The only side effect that was more frequent
with Diovan HCT than placebo was nasopharyngitis (2.4% vs 1%). In
individual studies, a dose-related increase in the incidence of dizziness
was observed Diovan HCT-treated patients.
