ARTICLE | Clinical News

Renagel sevelamer hydrochloride regulatory update

May 2, 2011 7:00 AM UTC

FDA issued a new quarterly report on safety information emerging from its Adverse Events Reporting System (AERS) during 4Q10 in which the agency identified a potential safety issue of esophageal obstruction in patients receiving Renagel sevelamer hydrochloride from sanofi-aventis' Genzyme Corp. subsidiary. The agency is evaluating the reports to determine if regulatory action is needed. Renagel is approved to control serum phosphorous in chronic kidney disease (CKD) patients on dialysis. Chugai Pharmaceutical Co. Ltd. (Tokyo:4519, Tokyo, Japan), which is majority-owned by Roche, has rights in Japan and certain Pacific Rim countries, while Kyowa Hakko Kirin has Chinese rights. ...