Biogen provided the following statement on the approval of Spinraza for SMA:
Dear Members of the SMA Community,
Today, the SMA community achieved a goal that would not have been possible without the support and dedication of the families, physicians and researchers who have passionately pursued a treatment for Spinal Muscular Atrophy (SMA). We are proud to announce that SPINRAZA™ (nusinersen) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of SMA in pediatric and adult patients.
We now enter the next phase of this journey, which is getting SPINRAZA to individuals with SMA. We know families will have many questions about what happens next. We always recommend you speak with your doctor about any medical questions you may have. Biogen has a dedicated team standing by to answer your logistical and product related questions. You can contact a SMA Support Coordinator at 1-844-4SPINRAZA (1-844-477-4672) 8:30am-8:00pm, Monday – Friday EST beginning today. Additionally, Biogen has created a support services program called SMA360°™*. SMA360° support provides certain services that address non-medical barriers to access. These include: logistical assistance, product education, insurance benefits investigations, and financial assistance. A complete list of the SMA360° offerings can be found in the coming days at www.spinraza.com.
This day could not go by without our heartfelt thanks to all the individuals and families who have participated in our studies and supported the SPINRAZA program. We would not have reached this historic moment without you and your contributions that have enabled the approval of the first treatment for the SMA community.
*SMA360° services from Biogen are available only to those who have been prescribed SPINRAZA in the U.S.
SPINRAZA is a prescription medicine used to treat spinal muscular atrophy (SMA) in pediatric and adult patients.
Important Safety Information
Increased risk of bleeding complications has been observed after administration of similar medicines. Your healthcare provider should perform blood tests at baseline and before each dose of SPINRAZA to monitor for early signs of these risks. Seek medical attention if unexpected bleeding occurs.
Increased risk of kidney damage, including potentially fatal acute inflammation of the kidney, has been observed after administration of similar medicines. Your healthcare provider should perform urine testing at baseline and before each dose of SPINRAZA to monitor for early signs of this risk.
The most common side effects of SPINRAZA include upper and lower respiratory tract infections, complete or partial collapse of a lung or lobe of a lung, constipation, headache, back pain, and post-lumbar puncture syndrome. These are not all of the possible side effects of SPINRAZA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
This information is not intended to replace discussions with your healthcare provider.
Please see full Prescribing Information for additional important safety information.
The Team at Biogen