2012年12月24日讯 --安斯泰来(Astellas)宣布,降压药Micamlo片获日本卫生劳动福利部(MHLW)批准。该药是首个高剂量血管紧张素II-1型受体阻断剂(ARB)替米沙坦(telmisartan,80mg)和长效钙通道阻滞剂(CCB)氨氯地平(amlodipine,5mg)的组合药物,具有强大的降压作用,持续时间可达24h。
英文原文:
Tokyo, Japan, December 21, 2012 - Nippon Boehringer Ingelheim Co., Ltd. (Headquarters: Shinagawa-ku, Tokyo; President: Yoshiaki Aono; hereinafter "NBI") and Astellas Pharma Inc. (Tokyo:4503, Headquarters: Chuo-ku, Tokyo; President & CEO: Yoshihiko Hatanaka; hereinafter "Astellas") today announced that they have obtained approval for manufacturing and marketing of "Micamlo? Combination Tablets BP," a combination drug of telmisartan 80 mg, a long-acting angiotensin II type 1 (AT1) receptor blocker (ARB), and amlodipine 5 mg, a long-acting calcium channel blocker (CCB).
"Micamlo? Combination Tablets BP" is the first combination drug of high dose ARB and CCB in Japan. While "Micamlo? Combination Tablets AP" is a combination drug of telmisartan 40 mg and amlodipine 5 mg, the amount of telmisartan in "Micamlo? Combination Tablets BP" has been increased to 80 mg. This is, therefore, expected to maintain a more potent antihypertensive effect for 24 hours compared with that of the conventional ARB/CCB combination drug.
"Micamlo? Combination Tablets BP" can be, in principle, administered when blood pressure is not adequately controlled by any one of treatments with "telmisartan 80 mg in combination with amlodipine 5 mg," "telmisartan 80 mg," "telmisartan 40 mg in combination with amlodipine 5 mg," or "Micamlo? Combination Tablets AP."
In a Phase III clinical study of "Micamlo? Combination Tablets BP" conducted in Japan, 173 patients analysed with essential hypertension not having achieved a blood pressure control target (diastolic blood pressure).