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Novartis: FDA concerned about Zolgensma's profile

( - On Wednesday Novartis has issued a statement to defend the safety and efficacy profile of Zolgensma, a paediatric treatment for spinal muscular atrophy challenged by the US health authorities.

In a statement yesterday, the FDA was informed by AveXis, Novartis' subsidiary behind this gene therapy, of a "manipulation" of data that were behind the drug's marketing approval last May.

While the FDA believes that there is currently no reason to withdraw Zolgensma from the market, the FDA assures that it takes the issue very seriously and is closely monitoring its development.

The agency even mentions the possibility of taking civil action, or even criminal prosecution.

Meanwhile, Novartis is trying to calm things down by guaranteeing that the data collected so far on Zolgensma confirm the product's safety and a risk/benefit profile that overall is favourable.

Zolgensma has been approved by the FDA for children under 2 years of age who suffer from proximal spinal muscular atrophy. The treatment is expected to be authorised in the European Union by the end of the year.

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