Tuesday, June 18, 2024

May 2024 Milestones for European Medicines Agency

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In a series of significant developments, the European Medicines Agency (EMA) has advanced its One Health agenda, recommended the suspension of certain drug authorizations, received World Health Organisation (WHO) recognition, and made several key approvals and updates, all highlighting its ongoing commitment to regulatory excellence and public health.

EMA launched a joint framework to promote the One Health agenda, addressing the interconnectedness of human, animal, and plant health, food safety, climate change, and environmental sustainability. This initiative aims to enhance the EU’s capacity to handle health threats, ensuring food security and environmental protection. A task force will implement the framework over three years (2024-2026), focusing on coordination, research, capacity building, stakeholder engagement, and joint activities. The agencies’ Executive Directors reaffirmed their commitment to One Health in a joint video statement.

Significant developments took place within the European Medicines Agency (EMA) and the European Medicines Regulatory Network (EMRN) On May. The EMA’s safety committee (PRAC) recommended suspending marketing authorizations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the EU. This decision followed a review indicating a possible increased cancer risk for individuals exposed to 17-OHPC in the womb and a lack of effectiveness in preventing premature birth. The PRAC concluded that the benefits do not outweigh the risks.

Just a few days later, the European Medicines Regulatory Network (EMRN) was designated as a WHO Listed Authority (WLA) by the World Health Organization. This recognition confirms that the EMRN, which includes the European Commission, EMA, and 30 national authorities, meets international regulatory standards. The designation underscores the EMRN’s commitment to regulatory excellence and international collaboration in safeguarding public health, promoting the safe, effective, and high-quality use of medicines globally.

Towards the end of the month, the EMA recommended conditional marketing authorization for Durveqtix (fidanacogene elaparvovec), a gene therapy for severe and moderately severe haemophilia B in adults without factor IX inhibitors and specific antibodies. Durveqtix, delivered as a single infusion, aims to enable the body to produce factor IX to control bleeding. Clinical trials showed a significant reduction in bleeding events. The CHMP’s positive opinion now awaits the European Commission’s decision for EU-wide marketing authorization.

European Medicines Agency

New guidance for the industry and notified bodies on medical devices was published. This question-and-answer document provides practical considerations for the implementation of regulations for combinations of medicinal products and medical devices. Depending on their primary mode of action, these products are regulated under either the pharmaceutical or medical device framework.

The guidance covers regulatory and procedural aspects for integral drug-device combinations (such as pre-filled syringes), co-packaged medicinal products with devices, and consultation procedures for medical devices with ancillary medicinal substances and companion diagnostics. The document supports the application of the medical devices (Regulation (EU) 2017/745) and in vitro diagnostic devices (Regulation (EU) 2017/746) regulations, which have introduced new responsibilities for EMA and national authorities. This revision is based on experience and actual cases since the regulations’ implementation.

EMA also recommended granting EU marketing authorization for Ixchiq, the first vaccine for adults aged 18 and older to protect against Chikungunya. Developed by Valneva Austria GmbH, Ixchiq is administered as a single dose. Clinical studies showed a strong immune response and maintained antibody levels up to 12 months post-vaccination. The vaccine’s safety profile was supported by data from 3,610 participants. The European Commission will now consider the marketing authorization decision.

The Committee for Medicinal Products for Human Use (CHMP) meeting from May 27-30, 2024, resulted in recommendations for 14 new medicines and extensions for seven existing therapies. Highlights include Adzynma, an enzyme replacement for a rare blood disorder, and Ixchiq, the first EU vaccine for Chikungunya. Notable approvals also included treatments for influenza, non-small-cell lung cancer, and severe hypoglycaemia.

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Additionally, biosimilar Avzivi received positive feedback for various cancers, and five generic medicines were endorsed. The CHMP reviewed and confirmed the refusal for Nezglyal and renewed the evaluation for Translarna. Updates were also made for Valdoxan’s product information and a reflection paper on Creutzfeldt-Jakob disease. The agenda and key statistics from the meeting are available on the EMA website.

Continuing with its efforts, the EMA published its 2023 annual report, detailing contributions to public and animal health in the EU. The report features strategic initiatives in cancer medicines, data-driven regulation, and transparency. Notable achievements include the recommendation of 77 medicines for human use, with significant advancements in therapeutic areas, including CRISPR/Cas9 gene-editing therapies. The report also highlights efforts to improve communication and transparency with the public.

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