Six biologics for rare diseases were approved either by US_FDA or EMA_News in 3Q22 but this year looks likely to be numerically the worst year for FDA approvals since 2016, according to our drug pipeline Data Page
With only nine approvals in 3Q, 2022 looks likely to be numerically the worst year for FDA approvals since 2016, with few small molecules approved and monoclonals down, too. Even so, six biologics for rare diseases were approved either by the US Food and Drug Administration or by the European Medicines Agency . Bluebird bio received FDA approval for two gene therapies within weeks of each other: Zynteglo for β-thalassemia and Skysona for adrenoleukodystrophy, a rare genetic disease .
The fourth quarter will bring two FDA decisions on monoclonal antibodies targeting different molecular species in the β-amyloid pathway as treatments for Alzheimer’s disease: Eisai/Biogen’s lecanemab, originating at the Swedish neuroscience company BioArctic, is an early pathway intervention that targets soluble Aβ protofibrils and aims to prevent plaque accumulation, while Lilly’s donanemab targets a pyroglutamate form of Aβ and aims to clear existing plaques.
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