Novartis submits ‘first in class’ blood pressure drug to EU regulator

Novartis has submitted an application to the European Medicines Agency for the approval of Rasilez, a drug described as the first in a new class of high blood pressure treatments.

The submission includes the results from 44 clinical trials involving over 7,800 patients, which demonstrated the drug’s ability to offer sustained, double-digit reductions in blood pressure.

In addition, Novartis claims the orally-taken drug is effective in combination with other types of blood pressure therapy, like beta blockers and angiotensin converting enzyme inhibitors.

Rasilez’s claim to be the first in a new class of blood pressure drugs is based on the fact that its action is based on the inhibition of renin, a chemical said to be crucial in regulating blood pressure.

James Shannon, global head of development at Novartis, commented: “For more than 40 years, medical researchers have focused on controlling over-activation of the renin system.

“As a direct renin inhibitor, Rasilez has the potential to redefine how high blood pressure is treated.”

Mr Shannon also revealed that Novartis was planning a large-scale clinical programme to study 40,000 patients to further research into the “potential long-term benefirst” of Rasilez.

Novartis currently markets Diovan, an angiotensin II receptor blocker (ARB), for the treatment of high blood pressure. It has a 30 per cent share in the ARB market and is the company’s largest selling drug.