Exactly two weeks ago, a meta-analysis study conducted here in the U.S. found an increased incidence of certain kinds of cancers -- in patients taking ARBs -- a class of blood pressure medicines that includes losartan.
Losartan, of course, is the generic chemical name for Merck's Cozaar® -- a rapidly swooning (now available as a generic) $3.5 billion a year worldwide franchise. Today, the European Medicines Agency, via its Committee for Medicinal Products for Human Use ("CHMP") will do a deeper dive on the data in that study, and make some inquiries of its own -- per Reuters reporting this morning:
. . . ."The CHMP will review the meta-analysis thoroughly, together with any other available non-clinical and clinical data. . . to clarify whether there is an increased risk of cancer in patients taking these medicines," the drugs agency said in a statement. . . .Other drugs in the class include Merck & Co's Cozaar, sold generically as losartan; Atacand, or candesartan, made by the Anglo-Swedish firm AstraZeneca (AZN.L), Diovan or valsartan made by Swiss drug firm Novartis, irbesartan, jointly marketed by Sanofi-Aventis and Bristol-Myers Squibb as Avapro, Daiichi Sankyo's Benicar or olmesartan, and Solvay Pharmaceuticals' Teveten or eprosartan.
The Medicines Agency said the CHMP would give an opinion after the investigation on whether changes should be made to the product information or risk-management plans for ARBs. . . .
We'll keep you posted. In other Europe news, Saphris® (branded there as Sycrest® -- chemical name: Asenapine) drew a positive review from the CHMP for treatment of manic bipolar episodes -- thus, it will likely be approved in the EU, within a couple of months.
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