Genzyme’s Ceredase
Executive Summary
Cost recovery charge for patients receiving glucocerobrosidase for Type I Gaucher's Disease approved by FDA on June 15. Range of "reasonable charges" has now been broadened to $20,000-$60,000. Ceredase has had an approved Treatment IND since November. The firm submitted cost data from Coopers Lybrand to support its recovery request: that could be an important precedent for future Treatment IND discussions with FDA.