In the United States allowed in emergency cases to use a new drug for COVID-19 based on antibodies
US Regulators Have Allowed Emergency Use of First Experimental Antibody Drug for COVID-19 in Patients Who Are Not Hospitalized But Are At Risk of Serious Illness Due to Their Age or Other Factors.
The Food and Drug Administration (FDA) approves Bamlanivimab for Eli Lilly & Co based on experimental data showing that a single injection reduces the need for hospitalization or emergency department visits in patients at high risk of COVID-19.
The drug is a monoclonal antibody. This is a widely used class of biotech drugs, which in this case is a manufactured copy of an antibody created by the human body to fight infections..
A similar treatment developed by Regeneron Pharmaceuticals Inc was assigned to the President of the United States Donald Trump after he got infected coronavirus in early October. Chief National Expert on Infectious Diseases Doctor Anthony Fauci said it probably contributed to the former president’s recovery.
The White House supported the FDA’s decision. The FDA said that Eli Lilly’s product & Co can be used by anyone over 65 who has recently been diagnosed with mild to moderate coronavirus, as well as for patients aged 12 and over who are at risk of serious illness.
It was not approved for hospitalized patients or those in need of oxygen therapy due to COVID-19, as it could worsen their condition.. The US government-sponsored Bamlanivimab study in hospitalized COVID-19 patients was recently discontinued as such treatment has not been proven to help..
At Eli Lilly & Co announced immediate start of supply of Bamlanivimab through distributor Amerisource Bergen, but regional logistics of the drug will be determined by the federal government.
The US government purchased 300 thousand doses of the drug and promised that Americans will not bear any out-of-pocket expenses for this drug. However, healthcare providers may charge a fee to administer the drug..
Serum maker expects nearly a million doses to be released for use worldwide by the end of 2020. Productivity is expected to increase from Q1 2021 as additional resources and network expansion will be deployed.
The FDA said that Eli Lilly & Co will maintain independence to review records, baseline data, and related discrepancies for Bamlanivimab, a drug produced at the company’s New Jersey plant..
According to Reuters, inspectors who visited the plant in November 2019 found that data on various manufacturing processes had been deleted and not properly verified..
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