No sweat for BioMarin at Vimizim panel; well, maybe a little
This article was originally published in Scrip
Executive Summary
If the members of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) are as placid as the agency seemingly appeared to be in briefing documents released ahead of the 19 November meeting of the outside advisers, BioMarin Pharmaceutical won't have much to sweat over, although that doesn't mean regulators didn’t raise some issues for the panel to sink its teeth into in mulling over the data for Vimizim (elosulfase alfa), an enzyme replacement treatment (ERT).