The U.S. FDA declines emergency approval for Humanigen’s COVID-19 drug

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The signage is seen outside the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, USA, on August 29, 2020. REUTERS / Andrew Kelly / File Photo

September 9 (Reuters) – The U.S. Food and Drug Administration rejected Humanigen Inc.’s (HGEN.O) application for emergency use authorization (US) for its drug lenzilumab for treat newly hospitalized COVID-19 patients, the company said Thursday.

“In its letter, the FDA stated that it was unable to conclude that the known and potential benefits of lenzilumab outweigh the known and potential risks of its use as a treatment for COVID-19,” the company said in a statement.

Humanigen expects an ongoing study to provide additional safety and efficacy data to support its new U.S. application.

The company filed the application with the FDA for emergency use of the drug in May, citing data from the final-phase trials.

Humanigen also began the UK authorization process for the drug in June through an ongoing submission of the review.

Aakriti Bhalla reports in Bengaluru; Edited by Shounak Dasgupta

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