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Biogen plans to make SPINRAZA available for shipment in the U. Biogen also plans to present results from the interim analysis of the Phase 3 ENDEAR study at the British Pediatric Neurology Association conference being held in , chief operating officer of Ionis."We look forward to receiving the first commercial revenues from sales of SPINRAZA next year.
SPINRAZA is the first and only treatment approved in the U. for SMA, a leading genetic cause of death in infants and toddlers that is marked by progressive, debilitating muscle weakness.
People with Type 2 and Type 3 produce greater amounts of SMN protein and have less severe, but still life-altering forms of SMA. ABOUT SPINRAZA (nusinersen)SPINRAZA is an antisense oligonucleotide (ASO) that is designed to treat SMA caused by mutations in the chromosome 5q that leads to SMN protein deficiency. Biogen and Ionis Pharmaceuticals acknowledge support from the following organizations for SPINRAZA: Cure SMA, Muscular Dystrophy Association, and SMA Foundation, intellectual property licensed from Cold Spring Harbor Laboratory and the .
It was discovered and co-developed by Ionis Pharmaceuticals, a leader in antisense therapeutics, and Biogen. regulatory agencies granted special status to SPINRAZA, including Fast Track Designation and Priority Review in the U. For additional information about SPINRAZA (nusinersen), please visit
SPINRAZA was discovered and developed by Ionis and Biogen, and licensed to Biogen who is responsible for future development, manufacturing, and commercialization of SPINRAZA.
In ENDEAR, a pivotal controlled clinical study, infantile-onset SMA patients treated with SPINRAZA achieved and sustained clinically meaningful improvement in motor function compared to untreated study participants.