A new treatment option gets FDA approval for adults with advanced Parkinson’s disease
The US Food and Drug Administration has approved VYALEV, a groundbreaking therapy developed by AbbVie to treat adults with advanced Parkinson's disease. This novel treatment is the first of its kind,
FDA Approves Vyalev for Advanced Parkinson Disease
The U.S. Food and Drug Administration has approved Vyalev (foscarbidopa and foslevodopa) for adults living with advan
AbbVie wins FDA nod for infusion treatment for advanced Parkinson’s disease
Vyalev is the first subcutaneous 24-hour continuous infusion of levodopa-based therapy for advanced Parkinson’s disease.
FDA Approves AbbVie's VYALEV as First 24-Hour Levodopa Infusion for Advanced Parkinson's
The first levodopa-based treatment for motor fluctuations in people with advanced Parkinson's disease, VYALEVa subcutaneous 24-hour continuous infusion of foscarbidopa and foslevodopais now authorized by the U.S. Food and Drug Administration, AbbVie ( ABBV, Financials) said Thursday.
3rd time's the charm: AbbVie scores FDA nod for continuous Parkinson's disease therapy Vyalev
AbbVie made history in 2015 with its Parkinson’s disease infusion pump therapy Duopa, kicking off a trend of delivery system innovation in the space as drugmakers sought to avoid the common pitfall | The 24-hour Parkinson's disease therapy crossed the FDA finish line after an initial manufacturing-related rejection last year and another snub in June.
After rejections, AbbVie secures approval for Parkinson’s drug
Vyalev’s clearance is the second victory for AbbVie in Parkinson’s this year, following an April readout for a drug acquired through its Cerevel buyout.
FDA Approves AbbVie's Parkinson's Treatment, Medicare Coverage Expected Next Year
Vyalev (foscarbidopa and foslevodopa) as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for motor fluctuations in adults with advanced Parkinson’s disease (PD). The approval was supported by the pivotal 12-week Phase 3 study evaluating the efficacy of continuous subcutaneous infusion of Vyalev in adult patients with advanced PD compared to oral immediate-release carbidopa/levodopa (CD/LD IR),
AbbVie’s Vyalev approved by FDA in advanced Parkinson’s disease
AbbVie announced that the FDA has approved Vyalev as the first and only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of motor fluctuations in adults with advanced Parkinson’s disease.
FDA approves AbbVie’s VYALEV for advanced Parkinson’s treatment
The US Food and Drug Administration (FDA) has approved AbbVie's VYALEV (foscarbidopa and foslevodopa) to treat motor fluctuations in adults with advanced Parkinson's disease (PD). The chronic neurological disorder is marked by symptoms such as tremors and muscle rigidity,
Medscape4d
FDA OKs Novel Levodopa-Based Continuous Sub-Q Regimen for Parkinson’s
Vyalev (AbbVie) is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy to address motor fluctuations in advanced Parkinson’s disease.
pharmaphorum4d
AbbVie gets continuous Parkinson's drug over the line in US
AbbVie has finally claimed FDA approval for its advanced Parkinson's disease therapy Vyalev, 18 months after the US regulator ...
Morningstar29d
Amneal Launches CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules for Treatment of Parkinson’s Disease
27 – Oct. 1, 2024 Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has launched CREXONT® (carbidopa and levodopa) extended-release ...
Medscape11d
Opicapone in Early Parkinson's: Time to Revisit Off-Label COMT Use?
New phase 3 results should reopen discussion about the off-label use of COMT inhibitors in early Parkinson's disease, experts ...