The US Food and Drug Administration (FDA) has narrowly beaten the European Medicines Agency (EMA) to the most approved drugs with a new active substance in 2024.

On 15 January, the two agencies released respective lists of medicines approved last year. The FDA approved 50 novel drugs that contained an active ingredient not previously approved by the agency, whilst the EMA authorised 46 new medicines.

Whilst racking up 50 novel drug approvals, the FDA approved fewer than it did in 2023, when there were 55 greenlit to market. Conversely, the EMA’s 2024 figure of 46 was a step up from the 39 new active substance drugs approved in 2023.

The highest proportion of new drugs approved by the EMA came in haematology/haemostaseology indications, with ten of the 12 approved medicines in this area containing a new active ingredient. Overall, however, oncology had the highest number of new drugs, matching trends seen in previous years. The FDA meanwhile highlighted the importance of rare diseases, reporting that over half its novel approvals came in orphan diseases that affect fewer than 200,000 people in the US. The FDA added that 68% of its novel drugs were approved in the US before any other country.

 

Mirrored approvals

Both the FDA and EMA approved Pfizer’s Hympavzi (marstacimab-hncq) for the treatment of adults and adolescents with severe haemophilia A or B without inhibitors. Hympavzi’s entry to market marked a significant advancement in treatment options available for patients with the rare disease, becoming the first approved anti-tissue factor pathway inhibitor.

In the hepatological space, both the FDA and EMA have approved Ipsen’s Iqirvo (elafibranor) and Gilead’s Livdelzi (seladelpar), the latter being marketed at Seladelpar Gilead in Europe. The drugs were approved for the treatment of primary biliary cholangitis, a chronic disease that can eventually lead to liver failure.

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