GlaxoSmithKline Building Photo: MedPageToday.Net

Regulators approve GlaxoSmithKline’s antibody drug against COVID-19

*The US regulatory authorities have found the drug to dramatically reduce the risk of Coronavirus hospitalisations or deaths of patients

Emmanuel Akosile | ConsumerConnect

The US Food and Drug Administration (FDA) has okayed emergency use authorisation to a monoclonal antibody drug, developed by GlaxoSmithKline (GSK) in partnership with Vir Biotechnology.

ConsumerConnect reports the regulatory agency approved Sotrovimab for treating mild to moderate COVID-19 in adults and pediatric patients aged 12 and older who are at a heightened risk of having a severe case of the virus.

However, it was learnt the drug is not for hospitalised patients or those who require oxygen therapy.

Patrizia Cavazzoni, M.D., Director of Center for Drug Evaluation and Research at FDA, in a statement said: “With the authorisation of this monoclonal antibody treatment, we are providing another option to help keep high-risk patients with COVID-19 out of the hospital.

“It is important to expand the arsenal of monoclonal antibody therapies that are expected to retain activity against the circulating variants of COVID-19 in the United States.”

In regard to reduction of the risk of severe symptoms in patients, in a trial involving 868 adults, the monoclonal antibody drug was shown to cut the risk of hospitalisation or death in “high-risk” adults by 85 percent.

Adverse events were generally mild or moderate and included rash and diarrhea.

GSK and Vir in a separate statement noted the Sotrovimab will be available for the patients that it’s intended to help “in the coming weeks.”

The companies said they plan to file for full approval of the drug sometime in the second half of this year.

Antibody treatments garnered attention, following former President Donald Trump’s contraction of COVID-19 and use of the drugs, report said.

Monoclonal antibodies are designed in a laboratory to replicate the immune system’s ability to fight viruses.

FDA further explained that “Sotrovimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2 and is designed to block the virus’ attachment and entry into human cells.”

Lilly has also received FDA authorisation for an antibody therapy that significantly reduces the risk of hospitalisation as a result of COVID-19.