The Food and Drug Administration (FDA) on Tuesday gave permission for emergency use for a new combination of antibody products from Eli Lilly, which according to the company can treat mild and moderate cases of the coronavirus.
FDA approval is for a treatment that uses both bamlanivimab and etesevimab. It can be used to treat mild or moderate cases of COVID-19 in adults and pediatric patients who are positive for the virus and who are at high risk of progressing to serious illnesses. The treatment can not be used for patients admitted to the hospital or requiring oxygen treatment of the coronavirus.
The FDA has previously approved a treatment of Eli Lilly, who has just been using bamlanivimab.
The new authorization allows the federal government to distribute the treatment to state and territorial health departments to donate to certain facilities.
“Today’s actions, which offer a different treatment for COVID-19, reflect the FDA’s strong commitment to work with sponsors to expand potential treatment options that healthcare providers can use to fight this pandemic,” said Patrizia Cavazzoni , acting director of the FDA’s drug center, said. Evaluation and research.
The authorization for emergency use follows data showing that bamlanivimab and etesevimab were co-administered, reducing the risk of COVID-19 hospitalizations and death by 70 percent.
Eli Lilly pointed out the authorization and noted that it would contribute to the bamlanivimab which is already in circulation and according to him helped reduce hospitalizations.
“Lilly has devoted our time, resources and expertise to discovering and developing therapies to treat COVID-19,” said Daniel Skovronsky, chief scientist at Eli Lilly. “Bamlanivimab alone under emergency use has already given many people an early treatment option that can prevent hospitalizations, and we are delighted to now add an additional therapeutic option with a similar clinical benefit.”
Eli Lilly produced 250,000 doses of the treatment during the first quarter of 2021 and plans to make as many as one million doses by the middle of the year.
The news comes as business declines across the country but remains at an alarmingly high level. There are still more than 27 million cases, and more than 468,000 people in the country have died from the virus. Concerns about the virus only increased as a number of variants – which appear more contagious than the original strain – spread around the world.
“With the risk of resistance emerging as different strains of the virus develop, bamlanivimab and etesevimab together may allow efficacy against a wider range of natural SARS-CoV-2 variants as these new strains spread around the world,” Skovronsky said.