U.S. FDA declines emergency use approval for Humanigen's COVID-19 drug (updated)

Humanigen

09/09/2021 05:55

(Adds details on company's plans, background)
    Sept 9 (Reuters) - The U.S. Food and Drug Administration
declined Humanigen Inc's  HGEN.O  request for emergency use
authorization (EUA) of its lenzilumab drug to treat newly
hospitalized COVID-19 patients, the company said on Thursday.
    "In its letter, 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.  urn:newsml:reuters.com:*:nBw1C3Ctqa
    Humanigen expects an ongoing study to provide additional
safety and efficacy data to support its new EUA request.
    The company filed its application with the FDA for emergency
use of the drug in May, citing late-stage trial data.
 urn:newsml:reuters.com:*:nL3N2NF38I
    Humanigen also started the process of UK authorization for
the drug in June through a rolling review submission.
 urn:newsml:reuters.com:*:nL3N2NW1DX

 (Reporting by Aakriti Bhalla in Bengaluru; Editing by Shounak
Dasgupta)
 ((Aakriti.Bhalla@thomsonreuters.com))