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Share Name | Share Symbol | Market | Type |
---|---|---|---|
AbbVie Inc | NYSE:ABBV | NYSE | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
-2.12 | -1.31% | 159.60 | 162.44 | 158.12 | 162.31 | 1,962,137 | 16:46:34 |
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)
Copyright (c) 2023 Dow Jones & Company, Inc.
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