AbbVie Inc. (NYSE: ABBV) provided a regulatory update on new drug applications (NDAs). ABBV-951 Wednesday Morning.
Things to know: AbbVie said it has received a response from the U.S. Food and Drug Administration (FDA) regarding its NDA for the treatment of movement fluctuations in adults with advanced Parkinson’s disease.
NDA is based on results from a Phase 3 clinical trial demonstrating statistically significant improvement in “on” time without complicating dyskinesias compared to oral immediate-release carbidopa/levodopa .
FDA did not request additional testing related to this drug, but the agency did Additional Information As part of that review, on pumping equipment.
“We look forward to working closely with the FDA as part of our commitment to bring this treatment option to people affected by this disease as soon as possible,” he said. Thomas HudsonSenior Vice President of Research and Development and Chief Scientific Officer of AbbVie.
Related item: Roche partners with Lilly to improve early diagnosis of Alzheimer’s disease
ABBV Price Action: AbbVie is trading between $134.10 and $175.90 over a 52-week period. Stocks were less responsive to Wednesday’s news.
AbbVie’s stock was down 0.41% to $156.14 at the time of the announcement, according to AbbVie. benzinga pro.
Photo: Courtesy of AbbVie.
Don’t miss real-time stock alerts – join us benzinga pro For free! Try tools that help you make smarter, faster and better investments.
This article AbbVie Provides Update on Parkinson’s Disease Treatment Candidate originally appeared benzinga.com
.
© 2023 Benzinga.com. Benzinga does not provide investment advice. all rights reserved.
