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First-In-Class Drugs Made Up More Than Half Of US FDA’s Novel Approvals Last Year

 
• By Bridget Silverman

CDER hit a high mark with 27 first-in-class approvals in the 50 novel agents cleared in 2021.

FDA first in class
MOST NOVEL PRODUCTS THAT GRADUATED FROM FDA’s DRUG CENTER in 2021 WERE FIRST IN THEIR CLASS. • Source: Nielsen Hobbs; the Pink Sheet | Alamy image

The US FDA’s Center for Drug Evaluation and Research didn’t turn in just a near-record high number of new molecular entity and novel therapeutic biologic approvals in 2021. The annual approvals class also features the strongest showing by first-in-class agents in recent years.

CDER classified 27 of the 50 novel agents approved in 2021 as first-in-class in the FDA center’s annual approvals report, a figure that stands out both as the highest proportion of first-in-class drugs (54%) and the largest number of

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