Novartis announced that the United States has become the first country in the world to approve Tekturna? (aliskiren), the first new type of medicine in more than a decade for treating high blood pressure – a condition estimated to affect nearly one billion people worldwide and still uncontrolled in nearly 70% of patients.
The US Food and Drug Administration (FDA) issued the approval for Tekturna as the first in a new class of drugs called direct renin inhibitors.
A once-daily oral tablet therapy, Tekturna acts by targeting renin – an enzyme responsible for triggering a process that can contribute to high blood pressure. This condition is a key contributor to cardiovascular disease, which remains the world’s leading cause of death.
Tekturna received FDA approval for treatment of high blood pressure as monotherapy or in combination with other high blood pressure medications. Tekturna is expected to be available in March in US pharmacies as 150 mg and 300 mg tablets.
“Renin angiotensin system activity contributes to many of the complications associated with high blood pressure,” said Marc A. Pfeffer, MD, PhD, Professor of Medicine at the Harvard Medical School and cardiologist at Brigham & Women’s Hospital. “By inhibiting this important system at its origin, renin production, a direct renin inhibitor such as Tekturna offers an exciting novel therapeutic option for treating hypertension.”
In an extensive clinical trial program involving more than 6,400 patients, Tekturna provided significant blood pressure reductions for a full 24 hours. Furthermore, Tekturna provided added efficacy when used in combination with other commonly used blood pressure medications. In clinical trials, the approved doses of Tekturna were generally well tolerated.
“Many patients require two or more medicines to control their blood pressure. As a new treatment approach, Tekturna has the potential to help these patients manage their disease,” said James Shannon, MD, Global Head of Development at Novartis Pharma AG. “Tekturna demonstrates our commitment to developing innovative medicines to help the millions of patients suffering from high blood pressure.”
Novartis is committed to conducting a large outcome trial program to evaluate the long-term effects of Tekturna and direct renin inhibition.
In September 2006, Tekturna, which will be known as Rasilez? outside the US, was submitted to the European Medicines Agency (EMEA) for review in the European U nion. Tekturna was developed in collaboration with Speedel.