Home / Health / EU Drug Review Delayed by US Facility Inspection
EU Drug Review Delayed by US Facility Inspection
20 Jul
Summary
- EU review of spinal muscular atrophy treatment may be delayed.
- Regulators await US FDA classification of a key manufacturing facility.
- European review depends on the outcome of an April inspection.
The European Union's review of Scholar Rock's experimental spinal muscular atrophy (SMA) treatment may be extended into later this year. European regulators are currently awaiting guidance from the U.S. Food and Drug Administration (FDA).
Specifically, the European Medicines Agency (EMA) needs the FDA's classification of Scholar Rock's Catalent Indiana fill-finish facility. This facility underwent an inspection in April, and its classification is now a prerequisite for the EMA's opinion on the drug.
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