The FDA has given the green light for Novartis' Tekturna, an potential blockbuster drug for hypertension. Tekturna is the first in a new class of drugs called direct renin inhibitors, which target an enzyme responsible for triggering a process that can contribute to high blood pressure. According to one analyst, Tekturna is poised to gradually replace the company's best-selling drug Diovan--which does $4.22 billion in annual sales--when the patent on that drug expires. Novartis licensed the drug from Switzerland's Speedel back in 2002. The approval is welcomed news for Novartis, which earlier this month suffered a setback when the FDA demanded another round of testing on Galvus, the company's diabetes drug.
"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."
- see Novartis' press release on the approval
- read The Wall Street Journal article on Tekturna
Novartis gets positive SPP100 Phase III results. Report
Galvus delay raises questions about drug class. Report
FDA demands new trial for Galvus. Report