AI Generated Image
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2026
European Medicines Agency (EMA) • • business
Key Points:
- The EMA’s CHMP recommended approval for six new medicines, including Aujemflu for influenza prevention in those 50+, Hopledo for Parkinson’s disease motor fluctuations, and Onswik for type 2 diabetes treatment.
- Positive opinions were also given for two biosimilars: Denosumab Ascend for bone complications and giant cell tumour of bone, and Nylaspeg to reduce neutropenia from chemotherapy.
- After re-examination, the CHMP recommended marketing authorisation for Daybu to treat neurobehavioural symptoms of Rett syndrome, but with a restricted indication.
- Negative opinions were issued for three medicines targeting advanced melanoma, HSCT-associated thrombotic microangiopathy, and acute graft-versus-host disease due to insufficient evidence or concerns.
- The committee recommended extending indications for 12 existing medicines, lowered the age limit for Imvanex vaccine to 2 years, started a safety review of Rifadin due to excipient concerns, and recommended revoking Tavneos’ marketing authorisation over data integrity issues.
