Celgene thalidomide NDA for leprosy to be filed by year end.
Executive Summary
CELGENE THALIDOMIDE NDA FOR ERYTHEMA NODOSUM LEPROSEM, a leprosy-related disorder, will be filed by year end, the company said. Pivotal trials of Synovir (thalidomide) for the indication have been completed. Celgene presented thalidomide trial data in closed session to FDA's Dermatologic & Ophthalmic Drugs Advisory Committee on Nov. 8.