Shots:
- The European Commission (EC) approved Daybu (trofinetide) and Hopledo (modified-release levodopa/carbidopa) for neurological disorders, expanding treatment options for Rett syndrome and Parkinson’s disease, respectively.
- Daybu was approved for neurobehavioral symptoms of Rett syndrome in patients aged ≥5 years, while Hopledo was approved for adults with Parkinson’s disease and moderate to severe motor fluctuations.
- The approvals add new treatment options for patients with complex neurological conditions, with Daybu moving toward EU pricing and reimbursement discussions and Hopledo set for a phased European launch from October 2026.
Company: Acadia Pharmaceuticals
Product: Daybu
Active Ingredient: trofinetide
Disease: Rett Syndrome
Date: Aug 20, 2026
Shots:
- The EC has approved Daybu (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in pts (≥5yrs.) across all 30 EEA states
- Approval was based on the results from the P-III (LAVENDER) study, which showed improvements in core features of Rett syndrome, as measured by RSBQ & CGI-I scale co-1EPs
- Daybu, a synthetic analog of the N-terminal tripeptide of insulin-like growth factor 1, will undergo pricing & reimbursement negotiations with EU national authorities as Acadia works toward potential patient access across EU
Company: Zambon
Product: Hopledo
Active Ingredient: modified-release levodopa/carbidopa
Disease: Parkinson’s Disease
Date: Aug 20, 2026
Shots:
- The EC has approved Hopledo for the treatment of adults with Parkinson’s disease & mod. to sev. motor fluctuations who have not been sufficiently stabilized with oral levodopa/DDC inhibitor-based treatments
- Approval was based on the P-III (RISE-PD) trial assessing Hopledo in pts with Parkinson’s disease & mod. to sev. motor fluctuations, which showed a significant increase in Good ON time over immediate-release LD/CD with fewer daily doses
- Hopledo is an oral, modified-release formulation of levodopa/carbidopa designed for the treatment of fluctuations of Parkinson’s disease, with a phased EU launch planned from Oct 2026
Note:
The following drugs have been approved; however, no PR was available:
- Aujemflu (Influenza vaccine)
