ROCHE’S ANTIBODY COCKTAIL(Regeneron’s casirivimab and imdevimab) GETS EMERGENCY APPROVAL IN INDIA

Ayomide Esther Fase

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cr: mbz-phptodesign / getty images

Do you know what is Antibody??

An antibody, also known as immunoglobulin, is a defensive protein formed by the immune system in response to the presence of an antigen, which is a foreign material. Antibodies identify antigens and latch on to them in order to eliminate them from the body. The body recognizes a wide variety of compounds as antigens, including disease-causing species and poisonous materials including insect venom. The immune system can identify an alien material as foreign when it reaches the body because molecules on the antigen’s surface vary from those present in the body. The immune system uses a variety of mechanisms to combat the invader, one of the most significant of which is antibody production. By binding to these invaders, the antibody can be able to prevent infection or mark them for immune cell destruction.

The very famous Antibody cocktail:

Since the beginning of the pandemic, every researcher has been up and down trying to find a cure to covid 19 one of the research is REGEN-COV. REGEN-COV (casirivimab plus imdevimab) is a combination of two monoclonal antibodies designed to stop the Covid-19-causing virus, SARS-CoV-2, from infecting people. The REGN-COV2 antibody cocktail used in these trials is a mixture of two virus-neutralizing antibodies that are both potent and complementary.

Regeneron Pharmaceuticals, an American biotechnology corporation, developed it as experimental medicine. It’s an “antibody mixture” created artificially to develop resistance to the SARS-CoV-2 coronavirus that caused the COVID-19 pandemic. Casirivimab (REGN10933) and imdevimab (REGN10987) are two monoclonal antibodies that must be combined. The use of two antibodies together is meant to avoid mutational escape. Regeneron scientists chose them after screening through thousands of possibilities. Each binds to the virus’s spike proteins, which form the corona we see in images of the virus. The virus can bind to and enter other cells thanks to those spikes. When the association is disrupted, the virus has a harder time binding to healthy cells.

When compared to placebo, casirivimab and imdevimab were shown to minimize COVID-19-related hospitalization or emergency room visits in people at high risk for disease progression within 28 days of treatment in a clinical trial of people with COVID-19. The safety and efficacy of this investigational therapy in the treatment of COVID-19 are still being assessed.

The data supporting casirivimab and imdevimab emergency use authorization (EUA) are based on 799 non-hospitalized adults with mild to moderate COVID-19 symptoms who participated in a randomized, double-blind, placebo-controlled clinical trial. Within three days of receiving a positive SARS-CoV-2 viral test, 266 participants received a single intravenous infusion of 2,400 milligrams casirivimab and imdevimab (1,200 mg of each), 267 received 8,000 milligrams casirivimab and imdevimab (4,000 mg of each), and 266 received a placebo. On day seven, the reduction in viral load in participants treated with casirivimab and imdevimab was greater than that in participants treated with placebo.

The most important evidence came from the predefined secondary endpoint of medically attended visits related to COVID-19 that the usage of casirivimab and imdevimab administered together may be effective, particularly hospitalizations and emergency room visits within 28 days after treatment. Hospitalizations and emergency room visits occurred in 3% of casirivimab and imdevimab-treated for participants with a high risk of disease development on average, compared to 9% of placebo-treated participants.

On the 19th of August 2020, Roche and Regeneron announced that they would collaborate to produce, manufacture, and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination, to people all over the world in the fight against COVID-19. REGN-COV2 has the ability to offer a much-needed treatment alternative for people who are already experiencing COVID-19 symptoms, as well as to avoid infection in people who have been exposed to the virus, slowing the global pandemic’s spread. This partnership is expected to boost REGN-COV2 supply to at least three and a half times current levels, with the possibility of even further expansion. REGN-COV2 was tested in two Phase 2/3 clinical trials for COVID-19 treatment and a Phase 3 trial for COVID-19 prevention in infected individuals’ household contacts.

On the 23rd of March 2021, Roche announced today that the largest trial to date evaluating a COVID-19 therapy in infected non-hospitalized patients (n=4,567; REGN-COV 2067) has yielded promising topline results. The primary endpoint of the phase III outcomes study in high-risk non-hospitalized COVID-19 patients was met, with the investigational antibody combination of casirivimab and imdevimab significantly reducing the risk of hospitalization or death by 70% (1,200 mg IV) and 71 percent (2,400 mg IV) relative to placebo.

Cocktail in india:

The number of coronavirus infections in India has surpassed 20 million, placing it second only to the United States. The official death toll is 226,188, but experts believe the true figure is far higher. India has granted emergency use approval for a COVID-19 antibody-drug cocktail produced by Roche (ROG.S) and Regeneron (REGN.O), promoting its drug arsenal in the face of a major second wave of infections. Roche’s India distribution partner for the drug, Cipla (CIPL.NS), said on Wednesday 25th of May, 2021 that the decision was made based on data filed with US regulators and the scientific opinion of a European regulatory panel. The drug already has a similar approval in the US and is used in non-hospitalized patients in Europe. When Donald Trump, the former president of the United States, contracted the disease, he took the drug.

The medication, according to Cipla, is intended for people who have a mild-to-moderate infection and are at a high risk of developing a serious disease. The company didn’t say how much it would cost or when it would be available. With the rising number of Covid-19 infections in India, Roche’s India MD said that the company is committed to doing everything possible to reduce hospitalizations and relieve pressure on healthcare systems.

Reference:

  • https://www.britannica.com/science/antibody
  • https://health.ucdavis.edu/health-news/newsroom/what-is-an-antibody-cocktail-and-what-trials-are-being-done-at-uc-davis-health/2020/10
  • https://en.m.wikipedia.org/wiki/Casirivimab/imdevimab
  • https://www.roche.com/media/releases/med-cor-2020-08-19.htm
  • https://www.reuters.com/world/india/india-approves-rocheregeneron-drug-covid-19-2021-05-05/

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