- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- Today, the FDA 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. Bamlanivimab is not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.
- In addition today, the FDA issued final guidance with the agency’s recommendations on designing and executing clinical trials of drugs and biologics that include people with different demographic characteristics (e.g., sex, race, ethnicity, age) and non-demographic characteristics (e.g., patients with organ dysfunction, comorbid conditions, and disabilities.) The final guidance provides the agency’s current thinking on steps to broaden eligibility criteria in clinical trials through inclusive trial practices, trial designs, and methodological approaches, as well as recommendations for how sponsors can increase enrollment of underrepresented populations in their clinical trials. This is particularly critical during the COVID-19 public health emergency as certain segments of the population are being affected by the virus in different ways. These health disparities illustrate why it is important for developers of any medical product, such as treatments or vaccines for COVID-19, to endeavor to include diverse populations to understand their risks or benefits across all groups.
- On Nov. 6, the FDA approved an abbreviated new drug application for cisatracurium besylate USP 10 mg/5mL and 200 mg/20 mL, which is indicated as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in certain pediatric patients by providing skeletal muscle relaxation during surgery, or for mechanical ventilation in the ICU in adults. The most common side effects of cisatracurium besylate injection include bradycardia, hypotension, flushing, bronchospasm, and rash. This drug is listed in the FDA Drug Shortage Database, and the agency remains deeply committed to facilitating access to medical products that are experiencing increased demand.
- Also last week, the FDA issued GenScript USA Inc. an EUA for its cPass SARS-CoV-2 Neutralization Antibody Detection Kit, which is the first serology test authorized to detect neutralizing antibodies from recent or prior COVID-19 infection. Neutralizing antibodies are antibodies that bind to a specific part of a pathogen and have been observed in a laboratory setting to decrease, in this case, SARS-CoV-2 viral infection of cells. However, the effect of neutralizing antibodies on SARS-CoV-2 in humans is still being researched.
- Testing updates:
- As of today, 288 tests are authorized by FDA under EUAs; these include 223 molecular tests, 58 antibody tests, and 7 antigen tests.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.