The FDA has approved a higher-dose regimen of Spinraza for spinal muscular atrophy, providing a new treatment option for patients.
The regimen includes 50 milligram per 5 milliliter and 28 milligram per 5 milliliter doses and is designed to deliver higher drug concentrations during both loading and maintenance phases, according to a March 30 news release from Biogen. It is expected to be available in the U.S. in the coming weeks.
The approval was based on a study evaluating the higher dose in both new and existing patients. Infants who received the higher dose demonstrated significantly improved movement and motor function compared to those who did not receive the treatment.
Patients new to Spinraza will receive two 50-milligram doses administered 14 days apart, followed by 28-milligram maintenance doses every four months. Patients transitioning from the lower-dose regimen will continue dosing every four months after a single high-dose loading phase.
The safety profile of the higher-dose regimen was generally consistent with the lower-dose version. Adverse events included pneumonia, COVID-19, aspiration pneumonia and malnutrition, each occurring in at least 10% of patients and at least 5% more frequently than in a matched control group.
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