Pharmaceutical Business review

Nippon Boehringer, Astellas Receive Micamlo Combination Tablets AP Manufacturing Approval

Telmisartan is an angiotensin II receptor blocker (ARB) and amlodipine besylate, a calcium channel blocker (CCB).

Nippon Boehringer and Astellas said that the Micamlo combination tablets AP is a combination drug of Micardis 40mg tablets, whose antihypertensive effect is known to last for 24 hours, and CCB amlodipine 5mg, with antihypertensive effect, together offering 24-hour sustained antihypertensive effects.

Micamlo combination tablets AP demonstrated an antihypertensive effect, lowering systolic blood pressure by -27mmHg from the baseline (8 weeks post dose), in a Phase III clinical study conducted in Japan with subjects not having achieved blood pressure control targets with amlodipine 5mg. The stably sustained 24-hour antihypertensive effect of the drug was confirmed in a study using ABPM (ambulatory blood pressure monitoring).

With the existing Telmisartan drug, Micardis tablets, and Micombi combination tablets, a combination drug of telmisartan and hydrochlorothiazide (HCTZ) diuretic of the thiazide class, Micamlo combination tablets AP constitute Micardis family.

Micamlo combination tablets AP is expected to be manufactured by Nippon Boehringer Ingelheim wherein Astellas will be responsible for the distribution and the drug will be co-promoted by both the companies.