Takeda says Edarbi now available in USA; progresses pancreatic cancer drug into Ph III

Following US Food and Drug Administration earlier this year, Japan’s largest drugmaker, Takeda Pharmaceutical (4502:TYO), says that its Edarbi (azilsartan medoxomil), an angiotensin II receptor blocker (ARB) approved for the treatment of hypertension, is now available by prescription for adults in US pharmacies (The Pharma Letter February 28).

The FDA cleared Edarbi as a once-daily oral therapy for use alone and for use in combination with other antihypertensive medications. Pivotal Phase III studies showed the drug (80mg/day) was statistically superior to the highest approved doses of two commonly prescribed ARBs, olmesartan medoxomil (40mg/day) and valsartan (320mg/day), in lowering both clinic systolic blood pressure (SBP) and 24-hour mean SBP as measured by Ambulatory Blood Pressure Monitoring (ABPM).

Takeda also announced that the FDA has approved updated product labeling for Edarbi, which highlights the connection between lowering blood pressure and decreased risks of cardiovascular outcomes, including strokes and heart attacks. The new product label reflects FDA guidance released in March 2011 for manufacturers of all antihypertensive treatments. The guidance stated, “blood pressure control is well established as beneficial in preventing serious cardiovascular events, and inadequate treatment of hypertension is acknowledged as a significant public health problem.”