U.S. health regulators have a newer, more convenient form Covid-19 antibody drug made
Regeneron Pharmaceuticals Co., Ltd.
The company said on Friday that patients could be more likely to receive treatment.
Doctors and nurses can now administer one of the new forms by simple injection instead of intravenous injection.
Regeneron’s monoclonal antibody drug, called REGEN-COV, has been available for the treatment of recently diagnosed Covid-19 since November last year under an emergency use authorization from the US Food and Drug Administration. In clinical trials, the drug reduced the risk of hospitalization and death in people with mild to moderate symptoms by 70%.
Regeneron’s Covid-19 antibody drug
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yet The drug is not used enoughAccording to public health officials, some require intravenous injections and not all clinics and hospitals can manage them.
Under the new approval, the FDA has allowed simpler prescriptions and allowed patients to receive injections under the skin if IV injections are infeasible or lead to delayed treatment, Regeneron said. He said.
In addition, the FDA has allowed the drug to be placed in a single vial. This can reduce the time it takes nurses to prepare for treatment.
REGEN-COV Combination of two monoclonal antibodies Prior to the latest FDA approval, the drug had to be stored in separate vials and mixed by the nurse before the drug was administered to the patient.
“Unfortunately, only a small percentage of patients who are eligible for antibody treatment have been treated so far, but we hope that it will change based on this updated FDA approval,” Regeneron said. George D. Yancopoulos, President and Chief Scientific Officer, said.
The FDA has also approved lower doses of the drug, which is about half the originally approved dose. This will increase the total dose available to patients under a contract between Regeneron and the US Government.
Regeneron said it plans to deliver at least one million doses to the government this quarter through June 30.
Antibody drugs are laboratory-created versions of natural antibodies produced by the immune system to fight the virus. Regeneron’s Covid-19 antibody is modeled on antibodies isolated from survivors of the disease and genetically engineered mice.
Regeneron of Tarrytown, NY, said laboratory tests showed that the drug remained. Effective against viral variants Scientists are worried that they may prove resistant to antibody drugs.
Rival antibody drug made by
& Co. Has proven to be ineffective against some viral variants, the US Department of Health and Human Services Stop shipping medicines to eight states Where the variants are widespread.
Regeneron said it would seek full approval of REGEN-COV later this summer. The company told the FDA earlier this year Prevent Covid-19 in people exposed to the virus People who have not been vaccinated yet Provide temporary protection Like people are waiting for a vaccine.
Third antibody drug from
Ville Biotechnology Co., Ltd.
PLC, was FDA approved last month.
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Regeneron’s Covid-19 drug is approved for injection
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