Novartis Targets Quick Launches For Zolgensma in Europe
Conditional Approval Finally Granted For SMA Gene Therapy
The Swiss major is offering a ‘Day One’ access program to governments and reimbursement agencies for Zolgensma, which is already available in France and will be shortly in Germany.
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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.
Novartis has completed its absorption of AveXis and rebranded the acquired gene therapy specialist that developed the soon-to-be SMA blockbuster Zolgensma despite struggling to meet the data integrity standards of regulators and big pharma.
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.