SCYOVA (foslevodopa/foscarbidopa) - Parkinson’s disease

The Committee deems that the clinical benefit of SCYOVA (foslevodopa/foscarbidopa) 240 mg/mL + 12 mg/mL solution for infusion is substantial in the MA indication.

Considering:

• demonstration of the superiority only versus oral levodopa/carbidopa after 12 weeks of treatment on:
  • change in average daily normalised “on” time without troublesome dyskinesia (primary endpoint): 2.72 hours versus97 hours, i.e. a mean difference of 1.75 hours (p = 0.0083),
  • change in average normalised “off” time (key secondary endpoint): -2.75 hours versus
    -0.96 hours, i.e. a mean difference of -1.79 hours (p = 0.0054),
• the absence of comparison versus the available second-line treatments for Parkinson’s disease, in particular apomorphine as continuous subcutaneous infusion, despite this being possible,
• the lack of quality of life evidence, in the absence of robust data,
• the safety profile of foslevodopa/foscarbidopa, marked by specific cutaneous adverse reactions,

the Committee deems that SCYOVA (foslevodopa/foscarbidopa) 240 mg/mL + 12 mg/mL
solution for infusion provides no clinical added value (CAV V) in the care pathway in the treatment of advanced levodopa-responsive Parkinson's disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results.