Junshi Biosciences gets FDA approval for etesevimab & bamlanivimab

Junshi Biosciences gets FDA approval for etesevimab & bamlanivimab

Junshi Biosciences, a biopharmaceutical company, has recently been awarded prolonged EUA (emergency use authorization) from the United States FDA (Food & Drug Administration) for extended use of its COVID-19 drugs, bamlanivimab and etesevimab.

According to Eli Lilly and Company (global partner of Junshi Biosciences), the two drugs can now be used together to treat high-risk pediatric patients (from birth to under 12 years old) from moderate coronavirus and post-exposure prophylaxis.

This joint treatment is the only authorized neutralizing antibody therapy for use in case of emergency in individuals suffering from COVID-19 under the age of 12. It provides treatment and inhibition options to high-risk individuals of any age.

In February 2021, the therapy was offered EUA by the FDA to treat mild to moderate COVID-19 in patients aged 12 and older who were at a higher risk of attaining severe COVID-19 and hospitalization.

In September 2021, the drug was sanctioned EUA for post-exposure prophylaxis in 12 and older individuals. 

It could be used by individuals who have not been vaccinated fully against COVID-19 or are not strong enough to produce an adequate immune response to complete vaccination. It could also be used to treat individuals who have been exposed to someone who is infected with the virus or who possess a high risk of exposure in an institutional setting, including a nursing home or prison.

The extended EUA is based on efficacy and safety data of pediatric and infant patients in BLAZE-1, a phase II/III clinical trial studying the two drugs for the treatment of mild to moderate COVID-19 and who are at high risk for severe progression.

According to reports by Lilly, around 700,000 patients have been cured with drug or bamlanivimab, preventing more than 35,000 hospitalizations and approximately 14,000 deaths during the worst phase of the pandemic.

Source Credit - https://www.globenewswire.com/news-release/2021/12/05/2346164/0/en/Junshi-Biosciences-Announces-FDA-Expanded-Emergency-Use-Authorization-for-Etesevimab-and-Bamlanivimab-Administered-Together-to-Include-Individuals-under-the-Age-of-12.html