FDA Rejects AbbVie Parkinson's Treatment; Seeks More Data
March 22 2023 - 9:44AM
Dow Jones News
By Colin Kellaher
AbbVie Inc. on Wednesday said the U.S. Food and Drug
Administration has turned away its proposed ABBV-951 treatment of
motor fluctuations in adults with advanced Parkinson's disease,
requesting more information about the pump used to deliver the
drug.
The North Chicago, Ill., biopharmaceutical company said the FDA
issued a complete response letter, indicating the agency wouldn't
approve the application in its current form.
ABBV-951 is an investigational combination of carbidopa and
levodopa, prodrugs commonly used to treat the neurodegenerative
movement disorder Parkinson's, delivered by a subcutaneous
pump.
AbbVie, which filed for FDA approval of ABBV-951 last May, said
the FDA didn't request any additional efficacy or safety trials
related to the drug, adding that it plans to resubmit its
application as soon as possible.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
March 22, 2023 09:29 ET (13:29 GMT)
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