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| Dear [Patient/Caregiver Name],
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| Thank you for your continued participation in the apitegromab Expanded Access Program (EAP). Your commitment has helped advance care for people living with spinal muscular atrophy (SMA), and we’re honored to have been part of your journey thus far.
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| We’re excited to share that, as of [date], apitegromab has been approved by the US Food and Drug Administration (FDA) with the brand name ISEMBYLD™ (apitegromab-mstn). Participants who wish to continue treatment will need to transition to commercial medicine (that is, receive
their infusions outside the context of the EAP) when the medicine becomes available.
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| The Transition Process
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| Individuals who wish to continue on ISEMBYLD now that it’s available beyond the EAP should work with their healthcare team on a treatment plan. We understand that patients will require insurance approval before they can transition to ISEMBYLD. Our priority is avoiding interruptions in care, and Scholar Rock is committed
to supporting EAP sites, patients, and families before, during, and after transition to help ensure seamless continuity of treatment with ISEMBYLD.
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| Welcome to Scholar Rock Supports
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| A dedicated team at Scholar Rock is here to help make your transition as smooth as possible. As your RX Onboarding and Care Coordinator (ROCC), I'll be reaching out with regular updates about coverage, affordability, and what comes next as you continue treatment.
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