pharmaphorum October 18, 2024
AbbVie has finally claimed FDA approval for its advanced Parkinson’s disease therapy Vyalev, 18 months after the US regulator turned it down with a request for more data.
Now, Vyalev (foscarbidopa and foslevodopa) has become the first subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson’s, delivered via a pump.
Questions about the pump used in the product led to the FDA’s decision to reject the marketing application in March 2023, but Vyalev will soon be an option for patients in the US who struggle to control symptoms throughout a 24-hour period using conventional oral Parkinson’s therapies.
AbbVie said in a statement that the timing of patient access to Vyalev is “dependent on...
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