AbbVie Issues Regulatory Update on New Drug Application for ABBV-951 to Treat Parkinson's Disease-March 2024-www.financetom.com

AbbVie Issues Regulatory Update on New Drug Application for ABBV-951 to Treat Parkinson's Disease

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AbbVie Issues Regulatory Update on New Drug Application for ABBV-951 to Treat Parkinson's Disease

Jun 25, 2024 6:51 AM

09:27 AM EDT, 06/25/2024 (MT Newswires) -- AbbVie ( ABBV ) said Tuesday that it has received a complete response letter from the US Food and Drug Administration for the New Drug Application for ABBV-951, to treat motor fluctuations in people with advanced Parkinson's disease.

The drugmaker said that the regulator cited issues from an inspection of a third-party manufacturer, and that the facility did not involve ABBV-951.

AbbVie ( ABBV ) said it is working with the FDA to address these observations and bring the therapy to patients.

AbbVie ( ABBV ) said there were no safety, efficacy, or labeling issues related to the drug were identified.

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