Medscape

FDA OKs New Formulation of SMA Gene Therapy Itvisma

Itvisma contains the active ingredient in Zolgensma approved in 2019 for children younger than 2 years but is reformulated ...

FDA approves Novartis’ Itvisma, first gene therapy for SMA patients 2 and older

Novartis ( NVS) on Monday said that the U.S. FDA has approved Itvisma for the treatment of children two years and older, ...
Managed Healthcare Executive

FDA approves $2.59 million gene therapy for SMA

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 ...
Pharmaceutical Technology on MSN

Novartis secures approval from FDA for Itvisma to treat SMA

The approval is supported by findings from the open-label Phase IIIb STRENGTH study and the Phase III STEER study.
BioWorld

Novartis’ Itvisma wins US FDA approval for SMA patients ages 2+

More than six years after Novartis AG’s Zolgensma was approved for children under 2 with spinal muscular atrophy (SMA) with biallelic mutations in the survival motor neuron 1 gene, the U.S. FDA ...
pharmaphorum

Novartis closes on EU approval for SMA gene therapy Zolgensma

Novartis is on the final straight to approval of its spinal muscular atrophy (SMA) gene therapy Zolgensma in the EU, after getting a recommendation for approval from the CHMP. The positive opinion ...
SMA News Today

FDA approves SMA gene therapy Itvisma for patients 2 and older

The U.S. Food and Drug Administration has approved Itvisma as the first gene therapy for spinal muscular atrophy patients ...