The General Council of Pharmacists has considered it to be a «very prolific» year, highlighting that nine of these active ingredients have been classified as «important innovation», although it has also emphasized that there has been a «significant amount» of active ingredients in orphan drugs with up to 16 of them.
Nearly half of the new drugs fall into the categories of antineoplastic therapies and immunomodulatory agents, followed by new active ingredients in the systemic anti-infective group, therapeutic groups for the digestive tract and metabolism, the cardiovascular system, and the nervous system.
Regarding the degree of innovation, the marketing of a «disruptive» gene therapy for hemophilia B stands out, the first treatment with a single intravenous dose with the potential for long-term disease control, which could mean the abandonment of periodic injections in certain patients.
Another innovative addition is lenacapavir, an antiretroviral drug with a novel mechanism of action that, while currently only indicated in rare cases of multi-resistant HIV-1 infection, is demonstrating in clinical trials that it can revolutionize general prophylaxis against the virus with just two annual injections.
In terms of Oncohematology, the antibodies elranatamab, teclistamab, and talquetamab have arrived, in addition to the «innovative» CAR-T idecabtagen vicleucel, which can «change the approach» to the most complicated cases of multiple myeloma.
Another of the innovative drugs that have arrived in Spain in 2024 is tirzepatide, a drug with a dual mechanism of action (GLP-1 and GIP receptor agonist), which has been approved for type 2 diabetes and weight control, and has the potential to become a «crucial» tool against obesity.
Throughout the year, three new biosimilar drugs have also been marketed, one for the active ingredient ustekinumab, one for ranibizumab, and the first biosimilar for natalizumab.
Of all the approved drugs, 84 percent have been single-component, 13 percent contained two active ingredients, and 3 percent were multi-component, maintaining the trend towards single-component drugs over the past decade.
Regarding the volume of medications, the number of commercially available presentations has decreased for the sixth consecutive year, with 867 new presentations being marketed, both for new active ingredients and existing ones, while 1,235 have been discontinued.
In the last ten years, 8,831 presentations have been added, accounting for just over 47 percent of the total available, and 10,903 have disappeared, reflecting a trend towards the renewal of the medication market.
FUENTE
