Vyalev, FDA and AbbVie
FiercePharma · 5d
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.
YAHOO!Finance · 4d
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.
McKnight's Long-Term Care News · 3d
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,
PMLiVE · 4d
AbbVie’s continuous Parkinson’s disease therapy Vyalev approved by FDA
AbbVie’s Parkinson’s disease (PD) therapy has been approved by the US Food and Drug Administration (FDA) to treat motor fluctuations in adults with advanced stages of the chronic movement disorder. Vyalev is a solution of foscarbidopa and foslevodopa,
The Pharma Letter · 4d
FDA finally approves Vyalev for Parkinson’s disease
After a couple of negative decisions, the US Food and Drug Administration (FDA) has approved Vyalev (foscarbidopa and foslevodopa), from AbbVie, 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 (PD).
AOL · 5d
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),
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