AbbVie receives CRL from FDA for NDA for ABBV-951

AbbVie announced it received a Complete Response Letter from the U.S. FDA for the New Drug Application for ABBV-951 for the treatment of motor fluctuations in adults with advanced Parkinson’s disease. In its letter, the FDA requested additional information about the device (pump) as part of the NDA review. The CRL does not request that AbbVie conduct additional efficacy and safety trials related to the drug. AbbVie plans to resubmit the NDA as soon as possible. "There is an unmet need for people living with advanced Parkinson’s disease as they face daily challenges in managing their condition," said Thomas Hudson, M.D., senior vice president, research and development, chief scientific officer, AbbVie. "We will continue to work closely with the FDA as part of our commitment to bringing this treatment option to people impacted by this disease as quickly as possible."