EMA: Withdrawal of an Application due to Missing Confirmation of a Manufacturing Site’s GMP Status
EMA reported that Scholar Rock Netherlands withdrew its application for Isembyld after evaluation had progressed through the final round of questions. EMA’s provisional view was that the medicine could not be authorised because the applicant had not provided confirmation that the manufacturing site complied with EU GMP requirements.
The case is notable because the unresolved issue preventing authorisation was explicitly manufacturing-site GMP status rather than clinical efficacy or safety. No further details were provided on the specific nature of the alleged GMP non-compliance.
Isembyld contains the active substance apitegromab and was to be available as an infusion (drip) given into a vein. Isembyld was developed for the treatment of 5q SMA, a condition which is linked to a defect on chromosome 5q.
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