Biogen Issues Q2 Community Statement on Spinraza

By Cure SMA | Published On June 7, 2019

Biogen Issues Q2 Community Statement on Spinraza

Dear members of the SMA community,

We are grateful for the opportunity to continue to help support individuals with spinal muscular atrophy (SMA), their caregivers and families. We deeply appreciate our shared goals and are dedicated to helping people with SMA, of all ages, and welcome the addition of new treatments in order to provide options across the spectrum of SMA.

Our support includes striving to expand access for all who may benefit from treatment with SPINRAZA® (nusinersen), the only therapy approved for all appropriate patients with SMA. In addition to providing an update regarding SPINRAZA’s real-world experience numbers, we are excited to share information on our continuous research and clinical development on SMA, the SPINRAZA clinical program, and our support services and educational programs for the SMA community.

Updated Real-World Evidence for Patients of All Ages

As of March 2019, more than 7,500 individuals* with SMA have been treated with SPINRAZA. Of these individuals, more than 2,700—ranging from three days to 79 years old‡—have received treatment with SPINRAZA in the U.S., where treatment sites can still be found across all 50 states.§ At the same time, real-world experience on SPINRAZA continues to increase, including in adults where more than 35 percent of the treated population in the United Sates is 18 or older. More than 95 percent of US patients who started on SPINRAZA remain on treatment. Our hope is that earlier initiation of treatment can lead to better outcomes for individuals with SMA.

Continuing SMA Research and Our Clinical Development Program

We continue to study SPINRAZA’s efficacy and safety in broad SMA populations. Our ongoing clinical trials add to the more than six years of data in the SPINRAZA clinical development program – the most robust clinical trial program in SMA to date – which includes more than 325 patients treated with SPINRAZA. Specifically, the open-label, supportive NURTURE trial represents the longest study of infants who began treatment with SPINRAZA during a pre-symptomatic period. This data is also consistent with the overall findings supporting the early initiation of treatment with SPINRAZA.

Providing Support Services for the SMA Community

As part of our continued mission to improve the lives of people with SMA, we would like to share information about the variety of programs and support services we provide for patients, families and caregivers:

  • The SMA360°™ program helps families who have been prescribed SPINRAZA navigate aspects of the treatment process. SMA360° teams include Family Access Managers (FAMs) and Lead Case Managers (LCMs), who assist with treatment logistics, insurance support and financial assistance programs, such as the $0 Copay Program. To gain access to these support services and additional information from Biogen, please register via SPINRAZA.com or call 1-844-4SPINRAZA (1-844-477-4672).
  • The Support and Treatment Education Program (STEP) is a program that offers free educational events about SPINRAZA and opportunities to connect with others in the SMA community. Events include in-person dinners and online webinars about topics such as multidisciplinary care, intrathecal administration and measuring motor function in SMA patients.
  • We are always looking for novel approaches to connect within the community and to share helpful information. One such example is our Facebook Live event that took place on March 12, 2019, and featured Dr. Anthony Geraci, a neuromuscular disease specialist, Michael N., a SPINRAZA Ambassador, and Rachel Naidich, a Biogen Family Access Manager (FAM). They discussed the importance of a multi-disciplinary approach to treating SMA in adults in addition to other important topics. This recorded event can now be viewed on the SPINRAZA Facebook page!

Above all, we remain committed to the SMA community by improving access to therapy through programs offered by SMA360° and by advancing SMA research. We look forward to sharing future updates about our research at upcoming conferences, including Cure SMA’s Annual Conference.

Best regards,

The Biogen SMA Team

INDICATION

SPINRAZA® (nusinersen) 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 before you start treatment with SPINRAZA and before each dose to monitor for 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 before you start treatment with SPINRAZA and before each dose to monitor for signs of this risk.

The most common possible side effects of SPINRAZA include lower and upper respiratory infections, 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.

Before taking SPINRAZA, tell your healthcare provider if you are pregnant or plan to become pregnant.

Please see full Prescribing Information.

This information is not intended to replace discussions with your healthcare provider.

5/19 SPZ-US-2704

*Based on commercial patients, early access patients and clinical trial participants as of March 2019.
† Includes clinical trial patients.
‡ Clinical studies of SPINRAZA did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger patients.
§ Based on commercial patients, early access patients and clinical trial participants as of March 2019.

Topics: Clinical Trials, Research, Front Page News

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