CRL setback for AbbVie's ABBV-951
US pharma major AbbVie (NYSE: ABBV) closed down almost 2% at $153.67 yesterday, after it revealed a regulatory setback for its investigational Parkinson’s treatment.
AbbVie said it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) 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. The agency has not asked for additional efficacy and safety trials related to the drug be conducted.
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