Biotech company Regeneron is planning to apply to the FDA for an antibody prophylaxis for the new coronavirus. (Getty Images)
Biotech company Regeneron said on the 12th that its antibody drug is effective in reducing 81% of symptomatic Newcastle pneumonia infections and plans to apply to the Federal Food and Drug Administration (FDA) for a prophylactic treatment.
Regeneron’s antibody drug has received FDA emergency use authorization for the treatment of patients with mild to moderate symptoms and those under 12 years of age, or at high risk of developing neoconjunctivitis. If authorized by the FDA, it will benefit unvaccinated, high-risk patients and those who have had a poor response to the vaccine.
This antibody drug is “passive immunity,” which injects antibodies directly into the body, unlike traditional vaccines that help the body produce antibodies after injection; therefore, while traditional vaccines take several weeks to produce antibodies, passive immunity provides immediate immunity.
The treatment was famous for treating former President Trump last year, but despite this, it was not widely used in hospitals because of the time-consuming need for intravenous drips; therefore, Regeneron will apply to the FDA to allow direct injection in the same trial.
The clinical trial with the National Institute of Allergy and Infectious Diseases (NIAID) involved 1,505 undiagnosed people living with sick patients, who were randomized to receive one dose of the antibody drug or a placebo.
After 29 days, 11 of the 753 people who received 1,200 milligrams of the antibody had developed symptoms, while 59 of the 752 participants who received a placebo had developed symptoms. The antibody drug produced 72% protection against symptomatic infections in the first week of vaccination, rising to 93% in the second week, although the study has not been formally released or peer-reviewed.
Regeneron also said that patients who received the antibody drug had their symptoms disappear within a week; those who received the placebo took three weeks; the antibody drug helped eradicate the virus more quickly, with no participants dropping out during the process.
None of the patients who received the therapy were hospitalized or sent to the emergency room with the disease within 29 days, compared with four in the placebo group; however, two people in the antibody drug group and two in the placebo group each died in the trial, but the cause of death was not a new crown or drug.
George Yancopoulos, president and chief scientific officer of Regeneron, said in a statement, “More than 60,000 people still get sick every day, and our antibody drug can help the unvaccinated public who have been exposed to the virus. We are also investing in research to see if the drug can help people who are not fully immunized and do not respond well to the vaccine.”
Biotech company Regeneron is planning to apply to the FDA for antibody prophylaxis.
Recent Comments