FDA says Novartis knew its application for $2.1 million gene therapy included errors

The Food and Drug Administration said Tuesday Novartis‘ application for its $2.1 million gene therapy for spinal muscular atrophy contained errors it knew about before approval.

In May, the FDA approved Novartis’ gene therapy, making it the world’s most expensive drug.

The therapy, Zolgensma, is a one-time treatment for spinal muscular atrophy, a muscle-wasting disease and leading genetic cause of infant mortality that affects one in every 11,000 births.

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