Dyax Submits HAE BLA

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Dyax Corp. has completed its BLA for DX-88 (ecallantide) for the treatment of hereditary angioedema (HAE). Dyax has requested Priority Review; if granted, this would set a target date of six months from receipt of the completed submission for the FDA to take action on the application. Priority designation is intended for those products that address unmet medical needs. DX-88 was previously granted Orphan Drug designation and Fast Track status by the FDA. The final portion of the BLA, the clin...

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