The experimental drug, Regeneron, given to President Trump to treat Covid-19 back in October, was granted emergency use authorization by the Food and Drug Administration (FDA) for the treatment of early viral symptoms. This is an encouraging shot of hope in the ever-expanding arsenal of drug therapies being given the green light to treat patients at high risk for developing severe disease. Previous drugs also fast-tracked and cleared by the FDA for Covid-19 use have been Gilead Sciences Inc.’s Remdesivir and Eli Lilly’s Bamlanivimab.
Developed by Regeneron Pharmaceuticals located in Tarrytown, New York, Regeneron consists of two monoclonal lab-made antibodies named basiliximab and imdevimab, a combination that went by the code name REGEN-COV2. By mimicking the body’s natural immune response, the combinations of the two antibodies are designed to attach to the virus targeting the spike protein preventing it from replicating and hijacking human cells. This action is meant to prevent individuals infected with the virus from developing severe symptoms, with the intention of reducing hospitalizations.
Hailed by President Trump, Regeneron was one of three medications given to him and was the one he credited as the cure for his recovery from Covid-19. Even Housing and Urban Development Secretary Ben Carson, who was recently infected with the virus, stated on Facebook he also had been cleared to use Regeneron which he too, attributed to saving his life.
Given as an infusion, Regeneron’s antibody cocktail is made for the treatment of non-hospitalized mild to moderate Covid-19 patients at high risk for developing severe symptoms. Patients eligible for use of Regeneron include children 12 years of age and older, anyone suffering from a chronic health condition, and people older than 65. However, the drug is not for use in patients already hospitalized with Covid-19 or who require oxygen therapy or on a ventilator due to concerns of making patients sicker.
The drug is still being tested in clinical trials evaluating it for safety and effectiveness for use in the treatment of Covid-19. But it was decided by the FDA to authorize emergency use helping speed up the drug’s availability due to the recent explosion of an upward trend in positive cases for coronavirus. Currently, more than 12 million U.S. citizens have been infected with the virus since March and more than 255,000 have died from it.
The decision was based on a clinical trial consisting of 800 participants which found that 3 percent of those given Regeneron and considered high risk for severe disease, required hospitalization or emergency room visits, compared to 9 percent of participants given a placebo.
Once again, thanks to the tremendous hard work and effort of the Trump Administration’s Operation Warp Speed, the U.S. government has already bought 300,000 doses from Regeneron at a cost of $1500 per dose as part of a $450 million contract signed in July with an option to buy hundreds of thousands more in time.
Currently, Regeneron Pharmaceuticals has stated it has enough doses to treat 80,000 patients by the end of November and projects another 120,000 doses by the first week of January and another 100,000 doses by the end of January 2021.
Distribution of Regeneron will take some coordination on decisions based on the number of confirmed cases in each state. However, officials with the Trump administration have stated their first priority is to be as fair as possible swiftly distributing the medication where needed most.
No doubt, Covid-19 cases are raging. However, our enhanced ability to effectively combating this virus thanks to innovative scientific researchers is a sure sign we are making significant strides in fighting this invisible enemy.
Right now, our primary focus should be on alleviating the tremendous burden on our healthcare system flooded with patients requiring hospitalization due to life-threatening, severe cases of Covid-19. From big-city medical centers to small rural town hospitals, our healthcare workers are taxed to the brink of working overtime caring for these patients. If we are unable to reduce the strain of overwhelming our hospitals, we will compromise our healthcare system’s ability to treat and care for other medical conditions unrelated to Covid-19. That’s why the FDA’s emergency use authorization of Regeneron and of other life-saving medications to treat Covid-19, is a glimmer of optimism and hope in our stressful situation.
We’ve come a long way since early March in achieving a better understanding of treating this disease. But we must continue to improve and perfect on preventing severe cases of Covid-19 keeping as many patients as possible out of the hospital and instead, allowing them to recuperate at home. Given the chance, I think all of us would much prefer that option anyway.