Recently, the European Medicines Agency (EMA) published an interesting overview of the performance for the year 2024 including figures on the authorisation of medicines and a selection of new treatments that represent significant progress in their therapeutic areas. Below some key achievements.
The EMA recommended 114 medicines for marketing authorisation, with 46 featuring new active substances never approved before in the EU. Among these groundbreaking treatments are:
- The first medicine for early Alzheimer’s disease
- A needle-free, smaller adrenaline option for allergic reactions
- The first treatment for von Hippel-Lindau disease-related tumours
- Two new antibiotics for severe infections
Innovations also extend to vaccines, with approvals for:
- Protection against Chikungunya disease
- A new mRNA vaccine for RSV (respiratory syncytial virus)
- Extended mpox vaccine use for adolescents (12-17 years)
Cancer treatment remained a top focus, with 28 oncology product recommendations. And also biosimilars saw major growth, making treatments for cancer, osteoporosis, and immune-related diseases more accessible and affordable. This progress highlights how science and innovation are shaping the future of medicine, ensuring safer, more effective treatments for patients.
Significant progress was also made in fast-tracking innovative treatments to patients:
- Accelerated Assessments: 3 medicines approved faster to address urgent public health needs.
- PRIME Program: 6 promising therapies received priority support and approval
- Conditional Approval: 8 medicines granted early access with ongoing data collection
- Approval under Exceptional Circumstances: 4 treatments approved for rare or complex conditions.
Other topics being addressed in the overview:
Medicines for Rare Diseases
In 2024, 15 orphan medicines had their designation confirmed, ensuring market exclusivity and incentives for developers to address rare conditions.
New Uses for Existing Medicines
90 treatments received extended indications, including 40 for paediatric use, expanding therapeutic options for patients.
Keeping Patients Safe
EMA and EU Member States continuously monitor medicine safety, taking regulatory actions such as label updates, suspensions, or recalls when necessary.
Ensuring Integrity in Clinical Trials & Manufacturing
EMA upholds EU standards globally, confirming the suspension of several generics tested by Synapse Labs (India) due to compliance concerns.
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