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.
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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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By GlobalDataThe agencies were also aligned on ARS Pharmaceuticals adrenaline-based nasal spray for anaphylaxis treatment. Marketed as neffy in the US and Eurneffy in Europe, the drug became the first needle-free adrenaline option for emergency treatment of allergic reactions. Its entry to market, despite a hiccup in 2023 when the FDA declined to approve it, is seen as a more convenient alternative to EpiPen.
Neuro differences
Perhaps the most significant contrasts came in neurological indications. First came the approval of the new Alzheimer’s treatment Kisunla (donanemab) by the FDA in July 2024. The drug, which is still being reviewed by the EMA, provides direct competition to Eisai and Biogen’s Leqembi (lecanemab), which the EMA approved in late 2024, more than a year later than the FDA. Both treatments are monoclonal antibodies that target beta plaques in the brain, though Kisunla is infused every four weeks rather than Leqembi’s two.
In September 2024, the FDA approved the first new schizophrenia drug in more than 30 years, courtesy of Bristol Myers Squibb’s (BMS) Cobenfy (xanomeline and trospium chloride). The approval validated the company’s $14bn acquisition deal for Karuna Therapeutics in which it gained rights to the candidate. BMS has not yet submitted Cobenfy to the EMA for marketing authorisation, though there are plans to run a UK trial in Oxford in 2025. Cobenfy is forecast to reach blockbuster status by 2028, as per GlobalData’s Pharma Intelligence Center.
GlobalData is the parent company of Pharmaceutical Technology.
Medications that received EMA approval but not FDA approval last year include Egetis Therapeutics’ Emcitate (tiratricol) and Pfizer’s Emblaveo (aztreonam-avibactam). Emcitate is the first treatment approved for peripheral thyrotoxicosis in patients with the ultra-rare chronic disease Allan-Herndon-Dudley syndrome while Emblaveo is indicated for certain types of infections by aerobic Gram-negative bacteria resistant to antibiotics.
