EMA panel issues negative opinion on Zevra arimoclomol EU marketing application for Niemann-Pick disease type C - ZVRA News | RalliesEMA panel issues negative opinion on Zevra arimoclomol EU marketing application for Niemann-Pick disease type C
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ZVRA• EMA panel gives negative opinion
- Zevra’s EU marketing application for arimoclomol in Niemann-Pick disease type C drew a negative opinion from the EMA’s CHMP.
- Re-examination request planned under EU procedures, keeping the product’s European approval timeline uncertain.
Expanded access program to continue
- Expanded Access Program to continue supplying arimoclomol to eligible patients while the regulatory path is pursued.
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