The FDA today approved a new drug called Tekturna to treat hypertension (high blood pressure).
Tekturna is the first FDA-approved drug in a new class of high blood pressure drugs called renin inhibitors. The kidneys make renin, an enzyme, to help regulate blood pressure.
Renin can raise blood pressure. Tekturna, taken once daily by mouth, blocks that process.
“Hypertension is rightly called ‘the silent killer’ because it usually has no symptoms until it causes major damage to the body organs,” says the FDA’s Douglas Throckmorton, MD, in an FDA news release.
Throckmorton is the deputy director of the FDA’s Center for Drug Evaluation and Research.
“Today’s approval adds a new safe and effective treatment option for people who need help to control their blood pressure,” Throckmorton says.
The FDA says Tekturna’s effectiveness in lowering blood pressure was demonstrated in six clinical trials that included more than 2,000 people with mild to moderate hypertension.
Patients either got Tekturna or a sugar pill (placebo).
Tekturna lowered blood pressure more than the placebo, says the FDA. Tekturna significantly reduced blood pressure for 24 hours, states a news release from Novartis, the drug company that makes Tekturna.
Tekturna’s blood pressure effects lasted for up to one year and was greater when Tekturna was taken with a diuretic, or water pill, according to the FDA.
In the clinical trials, Tekturna’s side effects were usually mild and brief, according to the FDA.
Diarrhea was the most common side effect associated with Tekturna. About 2% of the patients taking the higher of two Tekturna doses had diarrhea, compared with about 1% of those taking the placebo, states the FDA.
Other less common side effects included cough and rash, according to Novartis.
The FDA notes rare cases of allergic reactions in patients taking Tekturna. Those allergic reactions swelled the face, lips, or tongue, making breathing difficult. Such allergic reactions have been seen with certain other types of blood pressure drugs, the FDA notes.
Tekturna is one of several blood pressure drugs that should not be taken during pregnancy because it may cause injury or death to the developing fetus.
Novartis says it will do a large trial to track Tekturna’s long-term effects. Novartis is a WebMD sponsor.
SOURCES: News release, FDA. News release, Novarti