Here is our regular summary of content of relevance to neurology from the August 2025 issue of the the European Medicines Agency’s (EMA) newsletter
Key EMA News Updates:
Strengthening supply chain of anti-D immunoglobulins: EMA and HMA recommendations to address vulnerabilities in the supply of critical medicines used during pregnancy.
Click here for more details: Strengthening supply chain of anti-D immunoglobulins | European Medicines Agency (EMA)
New EMA webpage on risk minimisation measures: A risk minimisation measure (RMM) is intended to reduce adverse reactions of medicines, also called side effects. These measures and the risks they address feature in the product information of medicines authorised in the European Union (EU). Where needed, these measures may also feature in additional resources.
Click here for more details: Risk minimisation measures (RMM) | European Medicines Agency (EMA)
First reformulation of an inhaled medicine with environmentally friendly gas propellant: EMA has recommended a change in the composition of two inhaled medicines used to treat chronic obstructive pulmonary disease to replace the existing gas propellant with a low global warming potential alternative.
Click here for more details: First reformulation of an inhaled medicine with environmentally friendly gas propellant | European Medicines Agency (EMA)
Ixchiq: temporary restriction on vaccinating people 65 years and older to be lifted: EMA has completed its review of Ixchiq, a live attenuated chikungunya vaccine. The temporary restriction on vaccinating people aged 65 years and above, which was put in place during the review, has now been lifted. The review also considered cases of encephalitis (inflammation of the brain) with symptoms such as confusion, sleepiness, fever and headache. Cases of encephalitis are rare and the frequency with which they occur is not known.
Click here for more details: Ixchiq: temporary restriction on vaccinating people 65 years and older to be lifted | European Medicines Agency (EMA)
EMA Paediatric Committee elects Sabine Scherer as its new chair: EMA’s Paediatric Committee (PDCO) elected Sabine Scherer from Germany as its new chair for a three-year mandate, beginning in September 2025.
Click here for more details: EMA Paediatric Committee elects Sabine Scherer as its new chair | European Medicines Agency (EMA)
Information on medicines:
Voranigo (vorasidenib) – CHMP positive opinion on marketing authorisation: On 24 July 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the granting of a marketing authorisation for Voranigo, intended for the treatment of low-grade astrocytoma or oligodendroglioma with an isocitrate dehydrogenase-1 (IDH1) R132 or isocitrate dehydrogenase-2 (IDH2) R172 mutation in adults and adolescents aged 12 years and older and weighing at least 40 kg.
Click here for more details: Voranigo | European Medicines Agency
Kinsula (donanemab) – CHMP positive opinion after re-examination: On 24 July 2025, following a re-examination procedure, the CHMP adopted a positive opinion recommending the granting of a marketing authorisation for Kisunla, intended for the treatment of early symptomatic Alzheimer’s disease in adults who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes. The applicant is Eli Lilly Nederland B.V.
Click here for more details: Kisunla | European Medicines Agency (EMA)
Nurzigma (pridopidine) – Re-examination requested: Prilenia Therapeutics B.V. has requested a re-examination of the EMA’s July 2025 opinion on Nurzigma, intended for the treatment of Huntington’s disease. Once the grounds for this request are received, the Agency will re-examine its opinion and issue a final recommendation.
Click here for more details: Nurzigma | European Medicines Agency (EMA)
Aqneursa (L-acetylleucine) – CHMP positive opinion: On 24 July 2025, the CHMP adopted a positive opinion recommending the granting of a marketing authorisation for Aqneursa, an orphan-designated medicine for the treatment of neurological manifestations of Niemann-Pick Type C (NPC) disease in adults and children aged six years and older weighing at least 20 kg.
Click here for more details: Aqneursa | European Medicines Agency (EMA)
