bamlanivimab investigational monoclonal antibody therapy
Eli Lilly
INDICATION: 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, and who are at high risk for progressing to severe COVID-19 and/or hospitalization
ADDRESSING UNMET NEED: Monoclonal antibody for coronavirus treatment
MECHANISM OF ACTION: Monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’ attachment and entry into human cells
EFFECTIVENESS & SAFETY:
- Interim analysis from Phase II randomized, double-blind, placebo-controlled clinical trial, n=465 non-hospitalized adults with mild to moderate COVID-19 symptoms; several doses of bamlanivimab vs placebo
- Primary endpoint: Change in viral load from baseline to day 11; similar outcomes
- Secondary endpoint: COVID-19-related hospitalizations or emergency room visits within 28 days after treatment; 3% for bamlanivimab vs.10% for placebo
REGULATORY PATHWAY; EUA, Coronavirus Treatment Acceleration Program
cPass SARS-CoV-2 Neutralization Antibody Detection Kit
GenScript
INDICATION: Qualitative detection of total neutralizing antibodies to SARSCoV-2 in human serum and K2-EDTA plasma. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection
Emergency use of this test is limited to authorized laboratories
ADDRESSING UNMET NEED: First serology test authorized to detect neutralizing antibodies from recent or prior COVID-19 infection
ASSAY PRINCIPLE: Blocking Enzyme-Linked Immunosorbent Assay (ELISA) intended for qualitative direct detection of total neutralizing antibodies to SARS-CoV-2 in human serum and K2-EDTA plasma
FDA Guidance: Enhancing the Diversity of Clinical Trial Populations
Clinical trials design of drugs and biologics to include different demographic characteristics (e.g., sex, race, ethnicity, age) and non-demographic characteristics (e.g., patients with organ dysfunction, comorbid conditions, and disabilities)
- Addresses health disparities
- Critical during the COVID-19 public health emergency as certain segments of the population are being affected by the virus in different ways
- Developers of CVOID-19 treatments or vaccines for COVID-19 should include diverse populations to understand their risks or benefits across all groups
FDA Guidance: Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)
To help rapidly expand testing capacity by facilitating development and use of SARS-CoV-2 tests during the public health emergency
- Two policies for accelerating the development of certain laboratory developed diagnostic tests for COVID-19
- EUA submission to FDA
- No EUA submission when test is developed under State authorities and the State takes responsibility
Coronavirus Treatment Acceleration Program (CTAP) update
Special emergency program for possible coronavirus therapies
- Accelerate patient availability of new treatments while maintaining statutory standrads for safety and effectiveness
- Accelerate development and publication of guidances and other information for industry on developing COVID-19-related treatments
Fraudulent Flu Products
Unproven products that claim to prevent, mitigate, treat, or cure the flu
- Not been FDA approved for safety and effectiveness; can be ineffective and dangerous
- Might cause people to delay, forgo, or stop the medical treatment they need, leading to serious and life-threatening harm
- Ingredients could lead to unexpected side effects and interactions with other medications
- Can be found online, including popular marketplaces, and in retail stores
- Labeled as dietary supplements, foods, hand sanitizers, nasal sprays, or devices
READ Warning Letters page Fraudulent product views
Image credit: FDA, GenScript
