BioCentury
ARTICLE | Clinical News

Aprovel irbesartan regulatory update

July 15, 2013 7:00 AM UTC

EMA's CHMP recommended updating the labels of hypertension drugs Aprovel irbesartan and CoAprovel irbesartan/hydrochlorothiazide to include a contraindication for patients with diabetes or moderate to severe renal impairment (glomerular filtration rate <60 mL/min/1.73 m2) who take aliskiren-containing medicines. In the U.S., Aprovel is marketed as Avapro and CoAprovel is marketed as Avalide. Aprovel is also marketed to treat diabetic renal disease in patients with hypertension and Type II diabetes. CoAprovel is a combination of Aprovel, an angiotensin II type 1 (AT1) receptor (AGTR1) antagonist, and hydrochlorothiazide, a diuretic. Last September, Bristol-Myers returned to Sanofi worldwide rights to the drugs as part of the restructuring of a 1993 co-promotion deal. Bristol-Myers receives royalties on Sanofi's sales of branded and unbranded Avapro and Avalide through 2018 (see BioCentury, Oct. 8, 2012). In Japan, Dainippon and Shionogi have development and commercialization rights to irbesartan, where it is known as Irbetan, under a license from Bristol-Myers and Sanofi, respectively. ...