© Reuters. File photo: March 5, 2021, at the Eli Lilly and Company pharmaceutical plant at 50 ImClone Drive, Blanche, New Jersey. REUTERS/Mike Segar
(Reuters)-AstraZeneca (NASDAQ:), Eli Lilly (NYSE:), Regeneron (NASDAQ:) and GlaxoSmithKline (NYSE:) Stock code:) is one of the largest companies that use a class of drugs called monoclonal antibodies to develop COVID-19 treatments.
Monoclonal antibodies made in the laboratory mimic natural antibodies to fight infections. Unlike vaccines, they do not rely on the body to produce an immune response, so they can help individuals with weak or compromised immune systems.
The following is an overview of where the major drugmakers are in the development and regulatory process:
* AstraZeneca’s AZD7442 is a combination of two monoclonal antibodies, divided into two consecutive injections, designed to prevent and treat COVID-19.
* On October 5, it applied for emergency use approval (EUA) as a preventive drug to the US regulatory agency.
* On October 11, it stated that it will also submit new treatment data to global health regulators.
* On October 14, the European Union Drug Regulatory Agency stated that it had begun a real-time review of the therapy.
* In June, the drugmaker stated that a late-stage trial failed to provide evidence that the therapy can prevent individuals exposed to the virus from contracting the virus.
* In August, another trial showed that the therapy reduced people’s risk of developing any COVID-19 symptoms by 77%.
* Data on October 11 shows that AZD7442 reduces the risk of severe COVID-19 or death in non-hospital patients who have symptoms for 7 days or less by 50%.
* AstraZeneca said in March that it would provide up to 500,000 doses of drugs to the United States, extending the previous agreement reached in October for 200,000 doses of drugs. The transaction is subject to the FDA’s EUA.
* The British government also has an agreement in principle for more than one million doses.
Eli Lilly and Company
* American Pharmaceutical Group’s treatment is a combination of bamlanivimab and etesevimab antibodies, which is suitable for patients with mild to moderate COVID-19.
* In February, it was granted EUA by the FDA for the treatment of severe and high-risk patients who have not yet been hospitalized or require oxygen therapy.
* The U.S. Department of Health and Human Services suspended distribution in June after the drug failed to show effectiveness for several COVID-19 variants, but returned to some states at the end of August.
* In September, the FDA revised its EUA to apply it to high-risk patients exposed to the virus.
* Early data from a late-stage trial in January showed that the combination helped reduce the patient’s risk of hospitalization and death by 70%.
* January trial data on bamlanivimab, a component of the therapy, also showed that it can reduce the risk of infection for nursing home residents by 80%.
* Eli Lilly announced in September that it had reached an agreement with the European Commission to supply up to 220,000 doses.
* The United States purchased 100,000 doses of the diabody cocktail in February, followed by 388,000 doses of etesevimab in September. The country has pledged to purchase only 1,450,000 doses of bamlanivimab.
* GlaxoSmithKline and Vir Biotechnology (NASDAQ:) collaborated to develop the COVID-19 antibody drug sotrovimab.
* In May, the FDA granted sotrovimab an EUA for the treatment of mild to moderate COVID-19 in people 12 years and older.
* The European Union’s drug regulatory agency supported its use in June for patients at risk of serious diseases who do not require supplemental oxygen.
* It was approved as a COVID-19 treatment in Japan in September.
* A late-stage study in June showed that the treatment reduced the risk of hospitalization for more than 24 hours or death from any cause by 79%.
* The European Union signed a contract with GlaxoSmithKline in July to supply up to 220,000 doses of sotrovimab.
* It also signed an agreement to supply 10,000 doses of vaccine to Canada.
* The single-dose antibody cocktail Ronapreve, called REGEN-COV in the United States, was developed by Regeneron and Roche. It is a combination of two antibodies (casirivimab and imdevimab) and can be taken by injection or infusion.
* In mid-July, Japan became the first country to approve treatment, followed by the United States and the United Kingdom.
* REGEN-COV has now received emergency approvals in more than 20 countries for the prevention and treatment of the virus.
* On October 11, the EU drug regulatory agency stated that it is evaluating the effectiveness of the cocktail in the treatment and prevention of COVID-19.
* In June, a late-stage trial showed that cocktail therapy can reduce the risk of death by 20% for hospitalized patients whose own immune system fails to respond.
* In early April, it was revealed that REGEN-COV helped reduce the risk of symptomatic infection by 81% in a family whose other member was sick.
* It has also been found that this cocktail can effectively prevent COVID-19 in people who come into contact with an infected person, and another study has shown that it can fight Beta variants.
* As of September, the US government has purchased nearly 3 million doses.
* In June, the European Union received 55,000 doses of vaccine through a contract covering 37 European countries (including the United Kingdom and other non-EU countries).