Every drug ap­proved in 2022: A year of few­er new prod­ucts, but gene ther­a­py firsts and new block­busters

The year’s crop of US drug ap­provals won’t ri­val past vin­tages for quan­ti­ty. But of the 45 drugs cleared for use by the FDA in 2022, a third are shap­ing up to be block­busters, with high ex­pec­ta­tions for Lil­ly’s new di­a­betes drug, Bris­tol My­ers Squibb’s TYK2 in­hibitor and Gilead’s new HIV treat­ment.

The promise of gene ther­a­py be­came a re­al­i­ty in 2022, with new fund­ing for the FDA to work through its back­log of ap­pli­ca­tions, and three new ap­provals for blue­bird bio (for be­ta tha­lassemia and ear­ly cere­bral adrenoleukody­s­tro­phy) and CSL (for he­mo­phil­ia B). With those ap­provals came new break­throughs in price: The $2 mil­lion-plus treat­ment costs are like­ly to fur­ther test the bounds of the com­mer­cial mar­ket.

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