Plausibility Takes A Hit: FDA Revokes Orphan Exclusivity For Octapharma’s Wilate
This article was originally published in The Pink Sheet Daily
Executive Summary
In the first-ever rescission of marketing exclusivity for an orphan drug, FDA concludes that data does not show Wilate is superior to CSL Behring’s Factor VIII drug Humate-P. Wilate had previously been awarded orphan drug exclusivity for the same indication because of a “plausible hypothesis” that it was safer.
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