Atacand is now the only ARB to boast superiority in its labeling, in terms of blood pressure lowering, over the market leader and first entrant, Merck's Cozaar. However, the unique claim could be short-lived. Other newer agents in the class, also with proven superiority over losartan, are applying for similar labeling changes.
AstraZeneca has announced that the FDA has permitted it to include labeling superiority data on its angiotensin receptor blocker, Atacand (candesartan) over Merck & Co.'s Cozaar (losartan). This approval comes after the FDA's Cardiovascular and Renal Drugs Advisory Committee unanimously recommended allowing the comparative data in July 2002.
Results from two, eight-week trials involving more than 1,200 hypertensive patients demonstrated that Atacand reduces diastolic and systolic blood pressures statistically significantly more than Cozaar.
As the first drug in the ARB class to market, Cozaar has been used as the comparator in most of the head-to-head trials with newer ARBs. As a result, Cozaar has been losing ARB market share to the second-generation agents.
The LIFE trial results, presented at the American College of Cardiology meeting in March 2002, were the first to show mortality benefits for one class of antihypertensive over another. These were expected to help reverse the decline in Cozaar sales.
However, in another recent setback for Merck the OPTIMAAL trial results, presented at the European Society of Cardiology Congress in Berlin at the beginning of September, failed to demonstrate a benefit of Cozaar over ACE inhibition with captopril in the treatment of post myocardial infarction (MI) patients.
Things look unlikely to get any better for Cozaar - and Atacand should soon lose its competitive advantage. Although Atacand is currently the only ARB that is able to boast superiority in its labeling over other agents in the same class, it can now be expected that other companies with ARBs that have demonstrated superiority over losartan, will make similar applications to the FDA, to enhance their competitive positioning.
Indeed, the latest market entrant, Sankyo's Benicar (olmesartan), launched in the US in June 2002, may prove to be the most efficacious of all available ARBs.
Related research: Datamonitor, "Treatment Algorithms: Hypertension" (DMHC1786)
You can download a FREE cardiovascular report from www.dmfreereports.com