Edition:
United States

Galapagos: Gilead Plans To Submit New Drug Application For Filgotinib To FDA


Tuesday, 2 Jul 2019 01:00am EDT 

July 2 (Reuters) - Galapagos NV ::GILEAD ANNOUNCES INTENT TO SUBMIT NEW DRUG APPLICATION FOR FILGOTINIB TO U.S. FOOD AND DRUG ADMINISTRATION THIS YEAR.FILGOTINIB IS AN INVESTIGATIONAL AGENT AND NOT APPROVED ANYWHERE GLOBALLY.COMPANY DISCUSSED WITH AGENCY PHASE 3 FINCH STUDIES, AS WELL AS ONGOING PHASE 2 MANTA SAFETY STUDY.AS RESULT OF THIS DISCUSSION, A PATH FORWARD HAS BEEN ESTABLISHED TO SUBMIT NDA FOR FILGOTINIB AS TREATMENT FOR RHEUMATOID ARTHRITIS IN 2019.