Ann: COVID ARDS Trial Topline 60-Day Results, page-295

"When was the last EUA granted on a product with no previous label approvals?"

For a short period of time the investigational product bamlanivimab was granted an EUA until it became clear it was ineffective against new COVID19 variants.

On 9 November 2020, drawn from https://hotcopper.com.au/posts/48761060/single ;

"Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the investigational monoclonal antibody therapy bamlanivimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients.

Bamlanivimab is authorized for patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization. This includes those who are 65 years of age or older, or who have certain chronic medical conditions.While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo."

It did not reach the primary endpoint.

"The pre-specified primary endpoint in the phase two trial was change in viral load from baseline to day 11 for bamlanivimab versus placebo. Most patients, including those receiving placebo, cleared the virus by day 11. However, the most important evidence that bamlanivimab may be effective came from the predefined secondary endpoint of COVID-19-related hospitalizations or emergency room visits within 28 days after treatment. For patients at high risk for disease progression, hospitalizations and emergency room visits occurred in 3% of bamlanivimab-treated patients on average compared to 10% in placebo-treated patients. The effects on viral load and on reduction in hospitalizations and ER visits, and on safety, were similar in patients receiving any of the three bamlanivimab doses."

On April 16, 2021 it is reported Eli Lilly asks the FDA to revoke clearance of first COVID-19 antibody drug, bamlanivimab. It no longer worked due to changes in the dominant strain of Covid19. However the FDA revokes the EUA the same day.

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-revokes-emergency-use-authorization-monoclonal-antibody-bamlanivimab



The last of the current EUAs was granted on 30 April 2020 for a product to provide continuous renal replacement therapy (CRRT) to treat patients in an acute care environment during the COVID-19 pandemic. Not what you might strictly call a therapeutic, it is also listed under EUAs for Medical Devices.

From; https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

Of more direct interest is remdesivir or Veklury in relation to no label approval at the time of granting an EUA. It is an FDA approved product for use in adults now but when initially granted an EUA it was not. I have pasted my second post about remdesivir because I see the linked documents are not as they were on the date I posted, the current version of the document only relates to children under 12, not "certain people".



From; https://hotcopper.com.au/posts/44400494/single