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# FDA Extends PDUFA Action Date for Omeros’ BLA
- URL: https://www.fdaweb.com/fda-extends-pdufa-action-date-for-omeros-bla/
- Published: 2021-05-20T12:00:00.000Z
- Updated: 2026-09-14T16:59:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149370

FDA has extended to 10/17 the PDUFA target action date for Omeros’ BLA for narsoplimab to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy. The company [says](https://investor.omeros.com/news-releases/news-release-details/omeros-announces-extension-fda-review-period-narsoplimab-hsct?ref=fdaweb.com) that as part of the BLA priority review, it submitted a response to an FDA information request that the agency classified as a major amendment requiring additional time to review.

Narsoplimab has breakthrough therapy and orphan drug designations from FDA, Omeros says. The BLA was accepted for filing in January and given priority review status.