AbbVie Says FDA Has Approved Vyalev As First And Only Subcutaneous 24-Hour Infusion For Adults With Advanced Parkinson's Disease -- MarketWatch

MarketWatch · 10/17 12:12

AbbVie Inc. (ABBV) said Thursday the Food and Drug Administration has approved its vyalev as the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's disease. "For too long, the Parkinson's community has had limited treatment options for advanced disease. Due to the progressive nature of the disease, oral medications are eventually no longer as effective at motor symptom control and surgical treatment may be required," said Dr. Robert A. Hauser, professor of neurology at the University of South Florida, in prepared remarks. The approval was backed by a Phase 3 trial that found vyalev showed superior improvement in "on" time without troublesome dyskinesia and decreased "off" time, compared with oral immediate-release carbidopa/levodopa. AbbVie's stock was flat premarket but has gained 23% in the year to date, while the S&P 500 has gained 22.5%.

-Ciara Linnane

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October 17, 2024 08:12 ET (12:12 GMT)