Drugs

U.S. Approves More New Drugs than EU, Japan: Analysis

An IQVIA analysis of novel active substance (NAS) approvals in the U.S., the European Union (EU), and Japan from 2014-2022 found that the U.S. approved more NASs and approved them earlier on average than the EU and Japan. The report says the U.S. has continued to increase its margin of exclusive approvals.

U.S.-only NASs are concentrated in the oncology and neurology therapeutic areas, IQVIA says, are most often developed by emerging biopharma companies, and nearly half are first-in-class products.

Of the 545 NASs studied, 260 (48%) have been approved by regulators in all three jurisdictions. Another 121 (22%) were approved by the U.S. and EU only, and 34 (6%) were approved in the U.S. and Japan only. Some six products (1%) were approved only in the EU and Japan.

Of the 329 NASs approved by both FDA and the European Medicines Agency from 2014-2022, 260 (79%) were approved in the U.S. first. Across those shared approvals, the mean and median time to approval was 0.4 years faster and 0.5 years faster in the U.S. respectively, IQVIA says.

Of the 533 NASs approved by the U.S. and/or Japan, 285 (53%) were approved in both countries, while 185 (35%) were U.S. only and 49 (9%) were Japan only. Across the 285 shared NASs, the mean and median time to approval was 2.8 years faster and 1.3 years faster in the U.S., respectively.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome