US FDA Puts IT Zolgensma Studies On Partial Clinical Hold
Zolgensma And IV Studies Unaffected
The roller coaster ride for Novartis with its high-profile gene therapy Zolgensma continues as the FDA places a partial hold on trials of an intrathecal version aimed at older SMA patients on the back of nerve inflammation seen in a preclinical study.
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Novartis aims to double the addressable market for its spinal muscular atrophy gene therapy – and catch up to competitors – with the intrathecal version known as OAV-101.
The rollercoaster ride continues for Novartis’s gene therapy Zolgensma, with the company committing to providing further clinical data on an intrathecal formulation for older spinal muscular atrophy patients.
Biogen said some spinal muscular atrophy patients are currently being treated with Spinraza after receiving the Novartis gene therapy – its main competitor – so it will start a study of the risk/benefit in 2021.