Oxford GlycoSciences submits Vevesca NDA
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Oxford GlycoSciences completes its rolling NDA submission for the type I Gaucher disease therapy Vevesca (OGT 918) Aug. 21. The submission for the oral glycolipid storage disorders agent, initiated in March, includes data on use of the drug as monotherapy as well as in combination with Genzyme's Cerezyme (imiglucerase). Results of an extension study with Vevesca monotherapy will be presented Sept. 22 at the European Society of Glycolipid Disorders workshop in the Netherlands