EMA Greenlights Record Number of New Medicines in 2024
Table of Contents
The European Medicines Agency gave the nod to an unprecedented number of human and veterinary drugs, marking a banner year for pharmaceutical innovation.
The European Medicines Agency (EMA) reported a record-breaking year in 2024, recommending the approval of 114 new human drugs and 25 new veterinary drugs within the European Union. These figures represent all-time highs for both categories, according to the EMA’s recently released annual report.
The number of human drugs receiving positive recommendations from the EMA surpassed 100 for the first time in 15 years. The 25 veterinary drugs mark the highest number ever recommended for approval.
46 Novel Therapies Approved
Among the human drugs endorsed by the EMA’s Committee for Medicinal Products for Human use (CHMP), 46 contained entirely new active substances. Sixteen of these were designated for the treatment of rare diseases.
Emer Cooke, the EMA’s Executive Director, highlighted several key approvals in her introductory remarks: “Notable approvals include the first drug for the treatment of early Alzheimer’s disease, a nasal spray with adrenaline for allergic reactions, a treatment for tumors linked to von Hippel-Lindau’s disease and two new antibiotics for severe infections.”
“Notable approvals include the first drug for the treatment of early Alzheimer’s disease…and two new antibiotics for severe infections.”
Cancer Treatment Leads the Way
Other notable therapies approved by the EMA in the past year include Beqvez (Fidanacogene Elapsvovec), a gene therapy for Hemophilia B; Qalsody (Tofersen) for Amyotrophic Lateral Sclerosis (ALS); and the EU’s first vaccine against Chikungunya virus.
Cancer therapies received the most positive recommendations among all therapeutic areas.
The EMA’s annual report also details ongoing safety monitoring of approved medicines. Reviews by the Pharmacovigilance Risk Assessment Committee (PRAC) led to updates in the product information for 401 human drugs.
Record Approvals for Animal Medicines
The EMA also recommended the approval of 25 animal medicines in 2024, marking an all-time high. Fourteen of these veterinary drugs are vaccines.
Frequently Asked Questions
- What is the European Medicines Agency (EMA)?
- The EMA is a regulatory agency of the European Union responsible for the scientific evaluation, supervision, and safety monitoring of medicines in the EU. Source: EMA About Us
- What does the EMA do?
- The EMA ensures that all medicines available on the EU market are safe, effective, and of high quality. It reviews applications for marketing authorization, monitors the safety of medicines after they are approved, and provides scientific advice to companies developing new medicines. Source: EMA About Us
- How does the EMA decide whether to approve a new medicine?
- The EMA’s Committee for Medicinal Products for Human Use (CHMP) assesses the benefits and risks of a new medicine based on scientific data from clinical trials and other studies. If the CHMP concludes that the benefits outweigh the risks, it recommends that the European Commission grant marketing authorization for the medicine. Source: EMA Assessment Procedure
