In Part A of the trial, subjects will be given nine intravenous infusions of either the drug or placebo over a six-month ...
The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted Biogen’s applications for a higher dose regimen of spinal muscular atrophy (SMA) treatment Spinraza ...
Over the past nine years, patients with spinal muscular atrophy (SMA) have seen the number of FDA-approved treatment options for their disease go from zero to three. Now, an approval for a tablet ...
In 2016, Spinraza became the first approved treatment for SMA, with exceptional results in infants with severe SMA – so exceptional, it was considered unethical to continue enrolling children ...
The higher dose regimen of nusinersen comprises a more ... compared to the approved nusinersen regimen (Spinraza). The European Commission asked the CHMP to consider information on the safety ...
Biogen's treatment for neurodegenerative disorder spinal muscular atrophy (SMA) Spinraza has come under pressure in an increasingly competitive market, but the company hopes a new high-dose ...