On January 20, the official website of the State Food and drug administration showed that the listing application of Wutian pharmaceutical's class 1 new drug, olmesartan potassium tablets, had been approved by map. For the treatment of primary hypertension.
Angiotensin II is converted from angiotensin I under the catalysis of the angiotensin enzyme. Angiotensin II is the main pressor of the renin-angiotensin system, which has many physiological functions, such as promoting vasoconstriction, stimulating aldosterone synthesis and release, stimulating the heart,, and promoting renal sodium reabsorption.
Martin potassium is an angiotensin II receptor blocker independently developed by Takeda. It is an oral prodrug, which can be quickly metabolized into active ingredient azilsartan by esterase in the body during absorption. The latter can block the vasoconstriction and aldosterone secretion of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in many tissues such as vascular smooth muscle and adrenal gland. Its effect has nothing to do with the angiotensin II synthesis pathway. The affinity of azilsartan to the AT1 receptor is more than 10000 times that of the AT2 receptor.
At the 13th Oriental cardiology conference in 2019, Takeda announced the results of phase III clinical study of olmesartan potassium on the Chinese hypertensive population (nct02480764). A total of 612 patients with essential hypertension were enrolled in this study. They were randomly assigned to receive 80 mg (n = 209) of olmesartan potassium, 40 mg (n = 199) of olmesartan potassium or 160 mg (n = 204) of Valsartan for 8 weeks. The endpoints of the study included the changes of sitting systolic blood pressure (scuba) and sitting diastolic blood pressure (scuba) compared with baseline and the safety of the trough blood pressure (22-24 hours after the last administration) in the consultation room at week 8.
The results showed that the decline of scuba Valley in the 80 mg group was significantly higher than that in the valsartan group (- 24.2 vs. - 20.6 mmHg; P = 0.01), and the decline of scuba Valley in the 40 mg group was not worse than that in valsartan group (- 22.5 vs. - 20.6 mmHg, P = 0.18).
A total of 257 eligible subjects were included in the ABPM subgroup analysis. The results showed that at the 8th week, the SBP and DBP of 0-24 hours ambulatory blood pressure monitoring (8am-7am) in 40 mg and 80 mg groups were lower than those in the 160 mg group.
In terms of safety, the incidence of treatment-related adverse events (teams) in each treatment group was similar (52.8% ~ 56.5%), and tears were generally mild or moderate. The most common treatment-related team was dizziness (1.9% in the 80 mg group, 1.5% in the 40 mg group,, and 1.0% in the Valsartan group).
Based on the above research results, Takeda submitted an application for listing of olmesartan potassium to Tampa in July 2018.
Martin potassium was first approved by FDA in 2011. At present, it has been listed in more than 15 countries in the world, such as the United States, Canada, France,, and the United Kingdom. Nextparma database shows that in 2019, ascertain potassium brought Takeda a revenue of 76.7 billion yen, about 4.8 billion yuan.