(ANSA) – ROME, JULY 06 – Less than half of the new drugs approved by regulatory agencies add substantial therapeutic value to existing treatments: this is revealed by a study by the University of Zurich published in the British Medical Journal. Patients need better treatments, not just the same ones already being used, says lead author Kerstin Vokinger. New drugs are often used not only as a first indication for one disease, but also for other diseases (additional indications). But the study finds that less than half of the first indications approved for new drugs in the US and Europe between 2011 and 2020 add substantial therapeutic value over existing treatments, and only about a third of the additional approvals. The researchers looked at all newly approved drugs with more than one indication in the United States and Europe between 2011 and 2020 and assessed the therapeutic value of the additional indications compared to the initial indications.
They used publicly available data to identify 124 first indications and 335 supplemental indications approved by the US Food and Drug Administration (FDA) and 88 first indications and 215 supplemental indications approved by the European Medicines Agency (EMA) between January 2011 and December 2020 In the United States, 48% of drugs had only one supplemental indication, 20% had two, 14% had three, and 18% had four or more. In Europe, 48% of medicines had one additional indication, 23% two, 13% three and 17% four or more. The majority (58%) of the indications approved by the FDA and EMA were for anticancer drugs. Therapeutic assessments from French and German Health Technology Assessment (HTA) bodies were available for 107 (86%) early indications and 179 (53%) supplementary indications in the US and for 87 (99%) early indications and 184 (86%) supplementary indications in Europe. Of the FDA-approved indications with available ratings, 41% (less than half, 44 of 107) had high therapeutic value ratings for early indications, and 34% (61 of 179) for additional ones. In Europe, 47% (41 of 87) of the first indications and 36% (67 of 184) of the supplementary ones had assessments of high therapeutic value.
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