Here is our regular summary of content of relevance to neurology from the May issue of the European Medicines Agency’s (EMA) newsletter.
Key Updates:
- Joint Workplan on Data and AI: EU regulators have published a joint workplan to optimise the use of data and artificial intelligence across the network, ensuring adherence to high standards and consideration of new EU legislation.
Click here for more details: Leveraging the power of data for public and animal health | European Medicines Agency (EMA)
- Addressing Radiopharmaceutical Supply Chain Vulnerabilities: the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) has issued recommendations to address vulnerabilities in the supply chain of radiopharmaceuticals, aiming to align efforts among European and national authorities and the pharmaceutical industry.
Click here for more details: Tackling vulnerabilities in the supply chain of radiopharmaceuticals in the EU | European Medicines Agency (EMA)
- Public Consultation on Medicines Package Leaflets: the EMA is conducting a consultation on the potential addition of a “key information section” to the template for medicines package leaflets. The survey is open for feedback until 31 May 2025, and the EMA encourages responses, especially from patients and consumers.
Please click here for more details: Product-information (QRD) templates – Human | European Medicines Agency (EMA)
Medicines:
- Amvuttra (vutrisiran) – new indication: CHMP adopted a positive opinion to extend Amvuttra’s indication to include treatment of wild-type or hereditary transthyretin amyloidosis in adults with cardiomyopathy (ATTR-CM), in addition to its existing approval for stage 1 or 2 polyneuropathy (hATTR-PN).
Please click here for more details: Amvuttra – opinion on variation to marketing authorisation | European Medicines Agency (EMA)
- Dazluma (troriluzole) – application withdrawn: Biohaven Bioscience Ireland Limited withdrew its application for marketing authorisation of Dazluma for the treatment of spinocerebellar ataxia type 3 (SCA3).
Please click here for more details: Dazluma | European Medicines Agency (EMA)
