Novartis wins FDA approval for Itvisma, a one-time gene therapy offering broader SMA treatment with sustained motor function ...
Novartis ( NVS) on Monday said that the U.S. FDA has approved Itvisma for the treatment of children two years and older, ...
Onasemnogene abeparvovec-brve is the first gene replacement therapy approved for SMA patients aged 2 years and older, expanding access beyond infants. Phase 3 trials demonstrated significant motor ...
The FDA has approved Itvisma (onasemnogene abeparvovec-brve) to treat children two years and older, teens, and adults living with spinal muscular atrophy (SMA). It is indicated for patients with a ...
The approval is supported by findings from the open-label Phase IIIb STRENGTH study and the Phase III STEER study.
Novartis NVS obtained FDA approval for onasemnogene abeparvovec-brve, a gene replacement therapy, for children two years and older, teens, and adults with spinal muscular atrophy (SMA). The therapy ...
The U.S. Food and Drug Administration has approved Itvisma as the first gene therapy for spinal muscular atrophy patients ...
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