Annexon: EMA Grants Orphan Drug Designation To ANX005 In Treatment Of Guillain-Barré Syndrome

(RTTNews) - Annexon, Inc. (ANNX) announced the European Medicines Agency granted orphan drug designation to ANX005 for the treatment of Guillain-Barré Syndrome. Advantages of the orphan drug designation include protocol assistance, reduced fees for EMA procedures, a centralized EU approval process and ten years of market exclusivity.

The EMA orphan drug designation was based on an indirect comparison between ANX005 and intravenous immunoglobulin or IVIg. The EMA stated that preliminary clinical data with ANX005 constitutes a clinically relevant advantage over IVIg for patients affected by GBS.

The FDA previously granted orphan drug designation to ANX005 for the treatment of GBS.

Annexon said it is on track to report pivotal data in the first half of 2024.

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