AbbVie Receives A Complete Response Letter From U.S. FDA For The NDA For ABBV-951, For The Treatment Of Motor Fluctuations In Adults With Advanced Parkinson's Disease
Portfolio Pulse from Benzinga Newsdesk
AbbVie received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for ABBV-951, a treatment for motor fluctuations in advanced Parkinson's disease. The CRL was based on observations from an inspection at a third-party manufacturing facility and did not involve safety, efficacy, or labeling issues of ABBV-951. AbbVie is working with the FDA to address the concerns and bring the drug to market as soon as possible.
June 25, 2024 | 12:17 pm
News sentiment analysis
Sort by:
Ascending
NEGATIVE IMPACT
AbbVie received a CRL from the FDA for its NDA for ABBV-951 due to third-party manufacturing issues. The CRL did not raise safety or efficacy concerns. AbbVie is working to resolve the issues and bring the drug to market.
The CRL from the FDA is a setback for AbbVie as it delays the approval and market entry of ABBV-951. However, the absence of safety or efficacy concerns mitigates the negative impact. The stock may see a short-term decline due to the delay.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100