Roche's Blood Disorder Drug Crovalimab Takes Step Toward FDA Approval
06 September 2023 - 7:52AM
Dow Jones News
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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