GENENTECH WILL COLLECT MORE PULMONARY FUNCTION DATA ON CYSTIC FIBROSIS PATIENTS, BOTH THOSE TREATED WITH PULMOZYME AND UNTREATED AS PART OF PHASE IV WORK
Executive Summary
Genentech will collect long-term epidemiology data on a large group of cystic fibrosis patients to develop more information about changes in pulmonary function and parenteral antibiotic use over an extended period of time. The data collection is part of a five-point plan for follow-up research in the wake of the approval of Pulmozyme agreed to by Genentech in discussions with FDA and set forth in the final approval letter issued by the agency on Dec. 30.