Novartis files gene therapy Zolgensma for approval in Russia
Swiss pharma giant Novartis(NNVN: VX) has submitted a dossier to the Russian Ministry of Health for registration of its gene therapy Zolgensma (onasemnogene abeparvovec-xioi), which is intended for the treatment of spinal muscular atrophy (SMA).
If approved, Zolgensma will become the first gene therapy drug registered in Russia. As the company notes in its letter, the dossier will be reviewed by the experts of the Ministry within the timeframe set by the Russian laws and may take up to 12 months.
The drug is designed to address the genetic cause of SMA by replacing a defective or missing SMN1 gene to stop disease progression.
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