The US Food and Drug Administration (FDA) has permitted the emergency use of the first monoclonal antibody drug to help treat mild-moderate cases of Covid-19.
What We Know:
- Monoclonal antibodies are proteins created in a laboratory that imitate the immune system’s ability to fight off viruses. This particular lab-made antibody, bamlanivimab, works by identifying the SARS-CoV-2 pathogens (the virus that causes Covid-19) and then blocks the virus’ access and attachment to human cells. Bamlanivimab is a one time treatment through IV and is said to be similar to the treatment Trump received after he contracted the virus.
- The investigational drug from Eli Lilly can be administered to adult patients and pediatric patients over 12 that weigh at least 88 pounds. The drug is meant to help Covid-19 positive patients who are at high risk of hospitalization. This includes people 65 years and older or those who have chronic health conditions.When tested on patients already hospitalized due to coronavirus, research showed no benefits. The FDA news release explains monoclonal antibodies like bamlanivimab may worsen clinical outcomes if given to patients in the hospital who require high flow oxygen or mechanical ventilation due to Covid-19.
- The FDA says the safety and effectiveness of the antibody therapy is still being investigated. Nonetheless, in clinical trials it has shown to minimize the hospitalization of coronavirus patients and prevented high risk patients from emergency room visits within 28 days of treatment in comparison to placebo. Studies concerning the safety of the drug showed that out of 800 people, only one person had a severe allergic reaction.
- The decision to issue the emergency use authorization of bamlanivimab was based on interim analysis. Typically, the FDA needs substantial evidence to prove a drug to be safe and effective through meticulous controlled patient studies. Due to the urgency of relief necessary during this pandemic, standards can be lowered and simply require the possible benefits of an experimental treatment to outweigh the risks. The EUA serves as a temporary FDA approval during the pandemic. The government has agreed to purchase 300,000 vials at the cost of $375 million. It is unclear how many doses these vials will provide.
- FDA Commissioner Stephen M. Hahn, M.D. said, “the FDA remains committed to expediting the development and availability of potential COVID-19 treatments…while at the same time supporting research to further evaluate whether they are safe and effective”.
- Other companies like, Regeneron Pharmaceuticals Inc. have produced antibody drugs to help fight Covid as well. Trump received the biological therapy Regeneron in testing; they have also requested an emergency use authorization. Pfizer Inc. also announced their early data revealed their coronavirus vaccine to be 90% effective.
Fact sheets providing critical information concerning bamlanivimab when treating Covid-19 must be provided to health care providers, patients, and caregivers. The FDA site lists potential side effects as: anaphylaxis and infusion-related reactions, dizziness, nausea, headache, itching, vomiting, and diarrhea.
