EU approved 114 medicines in 2024

The European Medicines Agency has approved more than 100 new medicines for the first time in fifteen years. Of the 114 medicines given the green light in 2024, 48 contained new active substances and 16 were for the treatment of rare diseases.

Not since 2009 has the regulator backed so many new products, according to EMA Executive Director Emer Cooke. ‘This is good news for patients, but also a very encouraging indication of the competitiveness of the European pharmaceutical sector,’ she said.

It was a year of notable ‘firsts’, with the Agency backing the first medicine shown to slow the progression of Alzheimer’s disease in certain patients, as well as for the first vaccine to protect adults from Chikungunya, a virus transmitted to people by mosquitoes.

In an end of year message, Cooke also highlighted the challenge of antimicrobial resistance (AMR) which is estimated to cause 35,000 deaths in the EU every year: ‘It is worth mentioning EMA’s recommendation for marketing authorisation for a new antibiotic to fight infections caused by multidrug-resistant bacteria.”

2024 saw further progress on the transition of all ongoing clinical trials to the Clinical Trials Information System, which needs to be finalised by 30 January 2025. This marks the end of a three-year transition period that began when the Clinical Trials Regulation became applicable. Ten thousand applications have been submitted to the system since January 2022.

While the Agency highlighted successes in a range of areas, including international cooperation between regulators, it flagged the ongoing challenge of medicine shortages  in Europe which are putting pressure on patients, pharmacists, doctors and EU healthcare systems.

The EMA has stepped up efforts to address shortages of GLP-1 receptor agonists – a class of medication prescribed for people living with diabetes and obesity. The medicine has received significant media coverage for its positive impact on weight loss, leading to a surge in demand. This has left some patients unable to access a medication recommended by their doctors.

To tackle shortages more broadly, the regulator has launched the European Shortages Monitoring Platform (ESMP) to enable the exchange of information between regulators and pharmaceutical companies on supply problems.

Looking ahead, Cooke said the Agency will focus in 2025 on accelerating the assessment of key medicines, improving the availability of medicines, and future-proofing medicines regulation in the EU.