TGA publishes AusPAR for Zolgensma

MAESTrO Database

22 April 2021 - Rapid publication following approval.

Onasemnogene abeparvovec (Zolgensma) was approved by the TGA on 4 March 2021 (ARTG start date) for the treatment of paediatric patients less than 9 months of age with symptomatic or pre-symptomatic spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene and 1 to 3 copies of the SMN2 gene.

How is that an AusPAR for a new chemical entity can be published the month following its approval yet we are still waiting for the publication of AusPARs for other new chemical entities that were approved years ago?  Is there no penalty for the non-publication of an AusPAR? Senator Pauline Hanson needs to put some tough questions to the TGA.

Read AusPAR for onasemnogene abeparvovec

Michael Wonder

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Michael Wonder