EAST HANOVER, N.J., Aug. 27 /PRNewswire/ — The US Food and Drug
Administration (FDA) approved Tekamlo™ (aliskiren and
amlodipine) tablets, a single-pill for the treatment of high blood
pressure combining the only approved direct renin inhibitor,
Tekturna® (aliskiren), with the widely used calcium channel
blocker amlodipine. Tekamlo is approved as initial therapy for
patients who are likely to need multiple drugs to achieve their
blood pressure goals, and as replacement therapy for patients whose
blood pressure is not adequately controlled with either aliskiren
or amlodipine alone.
“We welcome the FDA’s decision to approve Tekamlo, as the
treatment of high blood pressure remains a challenge for many
patients, requiring multiple medications to control their
condition,” said David Epstein, Division Head of Novartis
Pharmaceuticals. “This approval reinforces Novartis’ commitment to
cardiovascular research and to developing innovative and effective
treatments for patients who have not reached their blood pressure
goal.”
The FDA approval of Tekamlo was based on clinical trial data
involving more than 5,000 patients with mild-to-moderate high blood
pressure. An eight-week, randomized, double-blind,
placebo-controlled, multi-factorial study showed that the
combination of Tekturna and amlodipine resulted in decreases in
systolic/diastolic blood pressure at trough of 14-17/9-11 mmHg,
compared to 4-9/3-4 mmHg for Tekturna alone, and 9-14/6-8 mmHg for
amlodipine alone.
In two additional double-blind, active-controlled studies of
similar design evaluating patients with moderate-to-severe high
blood pressure (SBP 160 – 200 mmHg), Tekamlo demonstrated
significantly greater reductions in systolic and diastolic blood
pressures when compared to amlodipine alone. In one
study of 443 Black patients, the systolic/diastolic treatment
difference between Tekamlo and amlodipine was 5.2/3.8 mmHg at the
primary endpoint of eight week
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