Japanese regulators have approved Takeda's Blopress in chronic heart failure (CHF), proving Takeda's lifecycle management strategy for the drug successful. Furthermore, the approval makes Blopress the first angiotensin receptor blocker (ARB) to be approved in CHF in all of the major pharmaceutical markets - Japan, the US and Europe - giving it a significant strategic advantage in this indication.
Takeda has announced the Japanese Ministry of Labour, Health and Welfare approval of Blopress (candersartan cilexetil) for the treatment of patients with mild to moderate CHF.
Blopress is already available in Japan for the treatment of hypertension, but seeking additional indications to maximize the drug's sales potential forms part of Takeda's aggressive lifecycle management strategy. As such, the company has also pursued further approvals for Blopress in CHF in the US and Europe, which have successfully led to it becoming the first in class to be approved for CHF in Japan, the US and Europe.
The CHF approvals for candesartan, which AstraZeneca markets under license as Atacand, are based on positive results from an AstraZeneca study program named CHARM. Results from this study identified candesartan to be the first ARB to reduce both death and heart failure hospital admissions in CHF patients with left ventricular systolic dysfunction, irrespective of
In addition, a new analysis of results from this study recently announced by Takeda has shown candesartan to be the first ARB to significantly reduce cardiovascular death and non-fatal myocardial infarction in heart failure patients, compared to placebo. This data, as well as the latest approval for Blopress, will no doubt further boost the product's sales.
Until recently, ARBs had largely been reserved for patients intolerant to ACE inhibitors, one of the most prescribed classes of drugs in CHF. However, ARBs are now also being used as an additional therapy in patients who remain symptomatic on the standard drug regime. The CHF approvals for Blopress thus affirm a continuing global shift in the use of this drug class in CHF.
ARBs currently approved in heart failure include candesartan and valsartan (Novartis' Diovan), although irbesartan (Bristol-Myers Squibb's Avapro), currently indicated for hypertension, is in phase III trials for a CHF indication and could prove a major competitor in this area. However, being the first ARB to be approved for CHF in the three major markets gives Blopress a much-needed advantage in this indication.