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AbbVie Gets Second Parkinson’s Drug With Vyalev Approval

 
• By Joseph Haas

Vyalev, a 24-hour constant infusion of carbidopa and levodopa prodrugs, obtained US FDA approval and will launch at $119,000 per year.

(Shutterstock)

After a quick resolution of a manufacturing-related complete response letter, AbbVie Inc. has the next piece in place for its Parkinson’s disease franchise. The US Food and Drug Administration cleared AbbVie’s subcutaneous combination therapy for the treatment of motor fluctuations in advanced Parkinson’s disease, Vyalev (foscarbidopa/foslevidopa), on 17 October.

Key Takeaways
  • AbbVie has obtained FDA approval of Vyalev, an injectable co-formulation of carbidopa and levodopa for advanced Parkinson’s disease.
  • The approval followed two complete response letters, including one tied to a third-party manufacturer’s site inspection this past June

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