Scholar Rock在美国获批后重新向EMA提交SMA疗法apitegromab上市申请

Scholar Rock Revives European Filing For SMA Therapy After U.S. Approval
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Biotech Daily Dose
Scholar Rock Revives European Filing For SMA Therapy After U.S. Approval
By
TajSabreen Ahamed
✉
Published:
10/8/2026 10:02 AM ET
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Scholar Rock (
SRRK
) has resubmitted its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of apitegromab for the treatment of children and adults with spinal muscular atrophy (SMA), a rare genetic neuromuscular disease that causes progressive muscle weakness.
The resubmission includes an alternative fill-finish manufacturing facility that replaces the previously referenced Catalent Indiana site. The new facility is the same one that supported the U.S.
FDA approval
of apitegromab, marketed as ISEMBYLD, in September 2026.
Scholar Rock previously withdrawn its European Application after the FDA classified the Catalent Indiana facility as "Official Action Indicated" (OAI)
SMA is caused by insufficient levels of survival motor neuron (SMN) protein, leading to muscle weakness and loss of movement. While currently available SMN-targeted therapies help address the underlying genetic cause of the disease, many patients continue to experience limitations in motor function.
Apitegromab is a muscle-targeted therapy designed to improve muscle strength and function in people receiving SMN-targeted treatments. According to the company, it is the first therapy of its kind to demonstrate motor function improvement in SMA patients already receiving an SMN-targeted treatment.
The application is supported by results from the Phase 3 SAPPHIRE trial, a randomized, placebo-controlled study. Scholar Rock reported that patients treated with apitegromab achieved clinically meaningful improvements in motor function after one year of treatment, while patients receiving SMN-targeted treatment alone experienced a decline in motor function.
Scholar Rock withdrew its earlier European application in August 2026 after identifying a manufacturing compliance issue at the Catalent Indiana facility; the company has now resubmitted the application.
The company expects the EMA's Committee for Medicinal Products for Human Use (CHMP) to issue an opinion on the application in the first half of 2027. If approved, apitegromab could expand access to the therapy for SMA patients across Europe.
SRRK has traded between $27.07 and $61.76 over the past year. The stock is currently trading at $41.48, down 1.71%.
For comments and feedback contact: editorial@rttnews.com
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