© Reuters/ANDREW KELLY FILE picture: Signage is viewed outside of FDA headquarters in White Oak, Maryland (Reuters) - The U.S. food and Drug Administration declined Humanigen Inc's request for emergency use authorization (EUA) of its lenzilumab drug to treat newly hospitalized COVID-19 patients, the business referred to on Thursday.
"In its letter, FDA cited that it become unable to conclude that the universal and talents benefits of lenzilumab outweigh the familiar and capabilities hazards of its use as a treatment for COVID-19," the business talked about in a statement.
Humanigen expects an ongoing study to supply additional safeguard and efficacy facts to support its new EUA request.
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The company filed its software with the FDA for emergency use of the drug in may, citing late-stage trial records.
Humanigen also begun the technique of UK authorization for the drug in June through a rolling assessment submission.
(Reporting through Aakriti Bhalla in Bengaluru; enhancing by Shounak Dasgupta)
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