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FDA Rejects Apitegromab for SMA Due to Fill-Finish Concerns

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Source: Scholar Rock
FDA Rejects Apitegromab for SMA Due to Fill-Finish Concerns
Photo: Scholar Rock
TL;DR Summary

The FDA issued a Complete Response Letter for Scholar Rock's apitegromab BLA due to manufacturing observations at a third-party facility, but no other approval issues were cited. Scholar Rock plans to resubmit after remediation of the manufacturing concerns, maintaining optimism about the drug's potential to treat SMA.

Topics:business#apitegromab#crl#fda#healthcare#scholar-rock#sma
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FDA Issues Complete Response Letter (CRL) for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA) Solely Related to Observations Identified at Catalent Indiana LLC Fill-Finish Facility  Scholar RockView Full Coverage on Google News

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