Biogen has announced new clinical data that demonstrates the significant benefits offered by its new spinal muscular atrophy drug Spinraza.
Results from the phase III ENDEAR study demonstrated a statistically significant reduction in the risk of death or permanent ventilation in Spinraza-treated infants with spinal muscular atrophy, compared to untreated infants.
“Biogen has reported new clinical data showing the benefits of its drug Spinraza in the treatment of spinal muscular atrophy.“
A 47 percent reduction in the risk of death or permanent ventilation was associated with the drug, with 68 percent of untreated infants experiencing these outcomes, compared to only 29 percent of infants treated with Spinraza.
It was announced that ENDEAR met its prespecified primary endpoint in August 2016, based on the proportion of motor milestone responders. Following a positive interim analysis, the study was ended early, giving all participants the option to receive Spinraza in an open-label extension study.
Dr Wildon Farwell, senior medical director for clinical development at Biogen, said: "We are very encouraged that individuals with spinal muscular atrophy have already started treatment with Spinraza this week in the US, and we continue to work closely with regulatory agencies to bring this therapy to patients around the world as quickly as possible."
The drug was approved by the US Food and Drug Administration last month.
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