FDA issues series of EUAs for COVID-19 therapies, at-home testing
Click Here to Manage Email Alerts
As cases spiked, the FDA issued a series of emergency use authorizations for therapies to treat patients with COVID-19.
The agency issued an emergency use authorization (EUA) for the monoclonal antibodies casirivimab and imdevimab (Regeneron Pharmaceuticals) to be administered together intravenously for the treatment of mild-to-moderate COVID-19 in adults and children aged 12 years or older with a positive SARS-CoV-2 test who weigh 88 pounds or more and are at high risk for progressing to severe COVID-19.
Adults aged older than 65 years who have certain chronic medical conditions also may receive the treatment. The authorization does not extend to patients who are hospitalized or require oxygen therapy due to COVID-19.
The combination is one of the treatments that was widely reported to have been given to President Donald J. Trump after he tested positive for COVID-19.
The EUA was based on a randomized, double-blind, placebo-controlled clinical trial of 799 nonhospitalized adults with mild-to-moderate COVID-19 symptoms. The FDA said the “most important evidence” to emerge from the trial was that only 3% of the monoclonal antibody recipients were hospitalized or visited an ED compared with 9% of those who received placebo.
The agency also noted that viral load reduction in patients who were treated with casirivimab and imdevimab was larger compared with patients treated with placebo at day 7. The effects on viral load, reduction in hospitalizations and ED visits were similar in patients receiving either of the two casirivimab and imdevimab dosages in the study.
“The FDA remains committed to advancing the nation’s public health during this unprecedented pandemic,” FDA Commissioner Stephen M. Hahn, MD, said in a news release. “Authorizing these monoclonal antibody therapies may help outpatients avoid hospitalization and alleviate the burden on our health care system.”
It was the second monoclonal antibody treatment for COVID-19 that the FDA authorized in less than a month. On Nov. 10, the FDA granted an EUA for Eli Lilly’s investigational monoclonal antibody therapy bamlanivimab to treat mild-to-moderate COVID-19 in the same group of patients who are covered in the EUA for casirivimab and imdevimab.
It is the same antibody treatment that former New Jersey Gov. Chris Christie said he received when he was recently hospitalized with COVID-19.
The EUA was supported by an interim analysis of a phase 2 randomized, double-blind, placebo-controlled clinical trial assessing the use of bamlanivimab in nonhospitalized adults with mild-to-moderate COVID-19 symptoms. During the ongoing study, researchers randomly assigned 452 patients to receive a single IV infusion of the therapy in one of three doses — 700 mg, 2,800 mg, or 7,000 mg — or placebo. The primary outcome was change in viral load from baseline to day 11.
As of Sept. 5, the time of the interim analysis, the study demonstrated a mean decrease of –3.81 from baseline in the log viral load for the entire study population, signaling an elimination of more than 99.97% of viral RNA.
According to the study, among participants who received the 2,800 mg dose, the difference from placebo in the decrease from baseline was 0.53 (95% CI, 0.98 to 0.08). The researchers reported that smaller differences from baseline were observed among patients receiving the 700 mg dose (0.2; 95% CI, 0.66 to 0.25) and the 7,000 mg dose (0.09; 95% CI, 0.37 to 0.55).
While safety and efficacy studies are still underway, the researchers determined that the patients who received the therapy had a slightly lower severity of symptoms than those who received placebo and that the percentage of patients who had a COVID-19-related hospitalization or visit to an ED was lower in the treatment group (1.6% vs. 6.3%).
The FDA also issued an EUA for baricitinib (Eli Lilly) in combination with remdesivir (Gilead Sciences) for patients hospitalized with suspected or confirmed COVID-19.
The EUA is specifically for hospitalized adults and children aged 2 years or older who require supplemental oxygen, invasive mechanical ventilation or extracorporeal membrane oxygenation, the FDA said.
The announcement followed the publicization of results from the ACTT-2 clinical trial, which demonstrated that patients with COVID-19 who were treated with baricitinib in combination with remdesivir had a lower median time to hospital discharge and lower mortality rates than patients treated with remdesivir alone.
The FDA issued an EUA for the first at-home COVID-19 test, the Lucira COVID-19 All-In-One Test Kit, a molecular, single-use test that provides results in 30 minutes or less.
The test is authorized for prescription use only and can be self-administered at home by individuals aged 14 years or older who are suspected of having COVID-19 by their health care provider. It can also be used in point-of-care settings such as doctor’s offices, hospitals, urgent care centers and EDs for patients of all ages. However, it must be administered by a health care provider for those aged younger than 14 years.
Collapse
Read more about
Click Here to Manage Email Alerts