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Novartis: FDA requests new study on AVXS-101

( - Novartis announced on Wednesday that the FDA has asked it to conduct an additional clinical trial on the intra-thecal formulation of AVXS-101, its gene therapy for spinal muscular atrophy (SMA), ahead of its potential approval.

The Swiss biopharmaceutical group emphasises that the request from the US health authority is not related to the partial clinical suspension affecting AVXS-101 IT, while specifying that the new study will not be launched until the FDA lifts its suspension.

Novartis stated that it remains confident in the risk/benefit profile of the treatment and added that the situation does not affect Zolgensma, its gene therapy for the treatment of spinal muscular atrophy in patients under two years of age, which is already approved in the US, Japan and Brazil.

The laboratory claims that more than 600 newly born babies have already benefited from Zolgensma to date.

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