Image Thumbnail

 

Biogen’s SPINRAZA™ (nusinersen) Receives Notice of Compliance from Health Canada for the Treatment of 5q Spinal Muscular Atrophy (SMA)

First SMA Treatment Approval in Canada

Mississauga, ON. July 4, 2017 – Biogen Canada Inc. today announced that Health Canada has approved SPINRAZA™ (nusinersen) for the treatment of patients with 5q spinal muscular atrophy (SMA). SPINRAZA is the first treatment to be approved in Canada for SMA, a leading genetic cause of death in infants and toddlers that is marked by progressive, debilitating muscle weakness.

SPINRAZA is indicated for the treatment of 5q SMA, which is the most common form of the disease and represents approximately 95% of all SMA cases.

“Today, Biogen is very proud to share the news that Health Canada has approved SPINRAZA for the treatment of 5q SMA. Based on the robust efficacy and safety profile demonstrated in the clinical trials, we believe SPINRAZA will have a meaningful impact on individuals living with this devastating disease,” said Wildon Farwell, Senior Director, Clinical Development at Biogen. “Biogen is committed and willing to continue to work with healthcare professionals, advocacy groups and government agencies to ensure people who could benefit from SPINRAZA receive access to this important treatment as quickly as possible.”

Read More

About SMA
Spinal Muscular Atrophy (SMA) is characterized by loss of motor neurons in the spinal cord and lower brain stem, resulting in severe and progressive muscular atrophy and weakness. Ultimately, individuals with severe SMA can become paralyzed and have difficulty performing the basic functions of life, like breathing and swallowing.

Due to a loss of, or defect in, the SMN1 gene, people with SMA do not produce enough survival motor neuron (SMN) protein, which is critical for the maintenance of motor neurons. The severity of SMA correlates with the amount of SMN protein. People with infantile-onset SMA, the form that requires the most intensive and supportive care, produce very little SMN protein and do not achieve the ability to sit without support or live beyond two years without respiratory support. People with later onset SMA produce greater amounts of SMN protein and have less severe, but still life-altering forms of SMA.