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) 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).

Developed by US pharma major AbbVie (NYSE: ABBV), the drug’s new drug application (NDA) was hit with an FDA complete response letter (CRL) in June this year, and in March of last year, the agency declined to approve the NDA and asked to see more information about the infusion pump.

AbbVie gained approval for the drug, under the trade name Produodopa, from the European Commission in January this year.