The rate of US Food and Drug Administration (FDA) approvals has been slower than for the same time last year. Notable registrations include small molecules Erivedge, a first-in-class Smoothened inhibitor for basal-cell carcinoma, and Kalydeco, a potentiator of G551D-mutated cystic fibrosis transmembrane conductance regulator for cystic fibrosis. The curse of neurodegenerative disorders again claimed two experimental drugs: Medivation's Dimebon and Trophos' Olesoxime. Shire ditched its US marketing application for Replagal, a human glucocerebrosidase available in Europe since 2001, after the FDA required further efficacy trials.
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Mak, C. Drug pipeline: 1Q12. Nat Biotechnol 30, 383 (2012). https://doi.org/10.1038/nbt.2210
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DOI: https://doi.org/10.1038/nbt.2210
