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# Evive Bio BLA for Neutropenia Therapy
- URL: https://www.fdaweb.com/evive-bio-bla-for-neutropenia-therapy/
- Published: 2021-03-31T12:00:00.000Z
- Updated: 2026-09-14T16:52:57.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149012

Evive Biotech has submitted a BLA for Ryzneuta (also known as F-627), indicated for treating chemotherapy-induced neutropenia. Neutropenia is a common chemo side-effect that is characterized by low levels of neutrophils, a type of white blood cell that fights infection, according to the company. It says Ryzneuta strengthens the immune system’s ability to fight infection by increasing the production of these white blood cells, thus preventing potential chemotherapy dose reductions and delays that may compromise treatment outcomes.

The submission is based on data from 10 clinical trials that enrolled over 1,200 patients to date in multiple territories including the U.S., EU, Australia, and China. Ryzneuta’s pivotal Phase 3 trial was conducted under a Special Protocol Assessment in agreement with FDA, Evive says.