FDA refuses to approve emergency use of Humanigen's COVID-19 drug
The U.S. Food and Drug Administration said Thursday that the U.S. Food and Drug Administration had denied Humanigen Inc's application for an emergency use authorization (EUA) for lenzelumab to treat newly hospitalized COVID-19 patients.
the company said in a statement."In its letter, the FDA stated that it was unable to conclude that the known and potential benefits of lenzelumab outweigh the known and potential risks of its use as a treatment for COVID-19,"
Humanigen expects an ongoing study to provide additional safety and efficacy data to support the new EUA request.
Last May 2021, The company submitted the documents to the U.S. Food and Drug Administration for emergency use, citing data from the previous stage of trials.
Humanigen also began the U.K. licensing process for the drug in June by submitting a renewed review.
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