China approved 1st new hypertension therapy over a decade

Novartis announced that the National Medical Products Administration of China has approved Entresto for the treatment of essential hypertension.

It's Entresto's second indication in China after it was approved for patients with heart failure with reduced ejection fraction in 2017.

The approval marks the first new drug in the treatment of hypertension in China over a decade, and it is set to drive the shift to leveraging integrated management of cardiovascular events in controlling blood pressure.

Entresto is a first-in-class angiotensin receptor neprilysin inhibitor. A phase III clinical study led by Professor Huo Yong from Peking University First Hospital, who is vice-chairman of the China Cardiovascular Association, showed that after eight weeks of treatment, Entresto demonstrated significantly better antihypertensive efficacy than olmesartan, which has the best antihypertensive activity among angiotensin II-receptor blockers, and significantly improved the percentage of patients with normal blood pressure readings. The study enrolled 1,438 Asian patients aged 18 and above with mild to moderate essential hypertension, of whom 85 percent are Chinese patients.

In addition, multiple studies showed that Entresto achieved the antihypertensive effect in a wider range of patients with hypertension, regardless of their blood pressure levels or the existence of risk factors or heart/kidney damage. Compared with conventional antihypertensive drugs, Entresto lowered blood pressure more effectively with unprecedented antihypertensive efficacy compared with the standard monotherapy. It also more effectively protected the heart, kidney and blood vessels, with a better safety profile.

Hypertension is the primary risk factor for cardiovascular events. China has 245 million adults with hypertension, but only 15.3 percent of them live with normal blood pressure levels. The damage to the heart, kidneys, blood vessels and other organs caused by hypertension has significantly increased the risk of cardiovascular death, leading to high hypertension-associated disability and mortality rates. Professor Yong Huo said, "In China, a lower percentage of patients with hypertension have normal blood pressure levels, and many of them face comorbidities and worsened target organ damage. In recent years, treatment of hypertension has started to focus on a strategy of lowering blood pressure, while, at the same time, reducing the risk of cardiovascular events and improving the prognosis.