Fda Approves Itvisma For Spinal Muscular Atrophy
Автор: RX Card Club
Загружено: 2025-12-08
Просмотров: 12
Описание:
The U.S. Food and Drug Administration has approved Itvisma (onasemnogene abeparvovec-brve) for the treatment of spinal muscular atrophy (SMA) in patients 2 years and older with confirmed mutation in the survival motor neuron 1 (SMN1) gene.
Itvisma is an adeno-associated virus vector-based gene therapy that is administered with a one-time, fixed-dose intrathecal injection.
The approval was based on data from the STEER and STRENGTH studies, which showed statistically significant improvements in motor function and stabilization of motor abilities in SMA patients.
The most common adverse events were upper respiratory tract infection, pyrexia, common cold, and vomiting.
The FDA's approval of Itvisma is a significant advancement in the treatment of SMA, expanding the use of transformational gene replacement therapy across age groups. #health #healthnews #medicine #medical #medicalnews #healthcare
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