By Cecilia Butini

Roche said Wednesday that the U.S. Food and Drug Administration has accepted its application for monoclonal antibody crovalimab for the treatment of rare blood condition paroxysmal nocturnal hemoglobinuria.

The government agency has accepted Roche's Biologics License Application, which is required to introduce a biologic product to the market, based on results from a Phase 3 study. It hasn't yet given the drug full approval, and the drug is still being investigated in a series of studies, Roche said.

If approved, however, crovalimab would be the first monthly subcutaneous treatment for paroxysmal nocturnal hemoglobinuria and would allow patients to self-administer the treatment outside of supervised health-care settings, according to the company.

Paroxysmal nocturnal hemoglobinuria causes symptoms like anemia, fatigue and blood clots, and affects about 20,000 worldwide, said Roche.

Write to Cecilia Butini at cecilia.butini@wsj.com

(END) Dow Jones Newswires

September 06, 2023 01:37 ET (05:37 GMT)

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