The Food and Drug Administration has given Japanese drugmaker Daiichi Sankyo the go-ahead to launch its new high blood pressure drug Azor on the US market.

Azor is a fixed-dose combination of two antihypertensives – the calcium channel blocker amlodipine (Pfizer’s Norvasc which recently went off-patent in the USA) and Daiichi Sankyo’s angiotensin receptor blocker Benicar (olmesartan), offering a double-edged attack on the condition.

The drug has certainly demonstrated its promise in clinical studies, inducing significant reductions in blood pressure in patients with hypertension. In the pivotal registration trial, Azor 10/40mg cut systolic blood pressure an average of 30.1mm Hg and diastolic by 19.0mm Hg. Moreover, when pitted against amlodipine 10mg alone, Azor 10/40mg resulted in a 53% greater reduction in the mean change of systolic blood pressure, the group claims.

“Azor is a valuable treatment addition, since so many people in the United States with hypertension do not have their blood pressure adequately controlled,” commented Michael Weber, Professor of Medicine at State University of New York, Downstate College of Medicine. “Azor, with its established efficacy and favourable side effect profile, provides two complementary mechanisms of action to lower blood pressure. It will give physicians a new treatment option for patients whose blood pressure remains too high on currently prescribed medications,” he explained.

Co-promotion deal

Just last month the company announced that is had signed up Forest Laboratories to co-promote the drug in the USA. Under the terms of the six-year deal, Forest will pay Daiichi Sankyo an upfront payment of $20 million and will receive an annual co-promotion sum based upon US product net sales. Daiichi Sankyo will bear all marketing and development expenses and both firms are to co-promote Azor during the first three years of the deal. This will be followed by a three-year period of residual payments for Forest during which it will no longer co-promote the product.