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 ...
Itvisma contains the active ingredient in Zolgensma approved in 2019 for children younger than 2 years but is reformulated ...
A next-generation treatment from Novo Nordisk helped patients with diabetes lower their blood sugar and lose weight in a ...
The U.S. Food and Drug Administration has approved Itvisma as the first gene therapy for spinal muscular atrophy patients ...
The approval is supported by findings from the open-label Phase IIIb STRENGTH study and the Phase III STEER study.