AbbVie Inc. has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for ABBV-951, a therapy intended to treat motor fluctuations in adults with advanced Parkinson's disease. The FDA's decision was based on observations made during the inspection of a third-party manufacturing facility listed in the NDA. This marks the second time the FDA has rejected AbbVie's continuous infusion therapy for Parkinson's disease. The regulatory setback, announced on Tuesday, has impacted AbbVie's stock, which fell by 0.6% in pre-market trading. AbbVie also issued a US Regulatory Update on ABBV-951 - SI.
US FDA rejects AbbVie's Parkinson's disease therapy for the second time https://t.co/cHjsIJ9qUs https://t.co/zyVyVxsTJB
AbbVie failed to win approval for a new Parkinson’s disease drug after US regulators found problems at a third-party manufacturing facility. https://t.co/ldxUudMDCx
FDA again rejects AbbVie's continuous infusion therapy for Parkinson's $ABBV https://t.co/l0FKiP3MkN
AbbVie said on Tuesday the U.S. Food and Drug Administration had declined to approve its therapy to treat motor fluctuations in Parkinson's disease patients, citing manufacturing concerns at a third-party manufacturer. https://t.co/XDa06Cb5fa https://t.co/XDa06Cb5fa
$ABBV (-0.6% pre) AbbVie (ABBV) Issues US Regulatory Update on ABBV-951 - SI https://t.co/H99d2zOMn1
$ABBV receives CRL for ABBV-951 NDA for the treatment of motor fluctuations in adults with advanced Parkinson's disease. CRL cited observations identified during the inspection of a third-party manufacturer listed in the NDA. The inspection at the facility did not involve…