FDA First-in-Class Drug Approvals

Key insights (2016–2025)

• • First-in-Class applies to 42% of all FDA novel drug approvals in this period (192 of 458 drugs).
• • Activity has held roughly steady at ~22/year in 2023–2025 vs 2020–2022. Peak year: 2021 with 27 approvals.
• • 124 unique sponsors received this designation; the top sponsor is Novartis (8 approvals). Top 5 sponsors account for 16% of all First-in-Class approvals.
• • 74% of First-in-Class drugs also received Priority Review designation — the most common pairing.