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FDA Rejects Scholar Rock's Drug Over Quality Control Issues

9/24/2025

Summary

Scholar Rock's Setback

The FDA rejected Scholar Rock's apitegromab due to persistent quality-control issues, including pest contamination at Novo Nordisk's facility.
Scholar Rock has not provided a timeline for resubmission, creating uncertainty about when the facility will meet FDA standards.
The setback underscores ongoing manufacturing challenges that can influence approval timelines, with Scholar Rock committed to addressing issues for future apitegromab trials.

Summary

Biogen's SPINRAZA Resubmission

The FDA issued a Complete Response Letter to Biogen's high-dose nusinersen (SPINRAZA), requesting technical updates only, with no clinical deficiencies cited.
Biogen plans to resubmit using readily available data, emphasizing commitment to SMA patients.
The high-dose regimen, already approved in Japan, is under review by the European Medicines Agency and other regulators.
SPINRAZA earned $1.57 billion in 2024, Biogen's second-highest-selling product.

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Scholar Rock's Setback

The FDA rejected Scholar Rock's apitegromab due to persistent quality-control issues, including pest contamination at Novo Nordisk's facility.
Scholar Rock has not provided a timeline for resubmission, creating uncertainty about when the facility will meet FDA standards.
The setback underscores ongoing manufacturing challenges that can influence approval timelines, with Scholar Rock committed to addressing issues for future apitegromab trials.

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