Biogen receives FDA approval for SMA drug

Biogen has received Priority Review approval from the US Food and Drug Administration (FDA) for its product Spinraza, which is used to treat patients with spinal muscular atrophy (SMA).
 
Spinraza has been licensed from Ionis Pharmaceuticals and is to enter the market with a list price of $125,000 (102,000 pounds) per dose. Patients will require five or six doses in their first year of treatment and three doses per year thereafter for the rest of their lives.
 
The news comes after the drug achieved sustained clinically meaningful improvement in motor function for patients in clinical trials when compared to untreated study participants. In addition, more patients on Spinraza survived than those not taking it.
 
Spinraza is currently the only drug to have received FDA approval for the treatment of SMA.
 
Chief executive of Biogen George A Scangos said: "Spinraza offers new hope for the SMA community and exemplifies our mission of applying cutting-edge science to make a meaningful difference in the lives of patients with devastating, life-altering diseases."
 
SMA is a genetic disease that results in muscle weakness and progressive loss of movement. It is caused by deterioration of the motor neurones connecting the brain and spinal cord to the body's muscle and is a leading genetic cause of death in infants and toddlers.

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