FDA Grants Emergency Use Authorization to Junshi Biosciences and Eli Lilly's Etesevimab/Bamlanivimab Dual Antibody Therapy Amid Global COVID-19 Cases Surpassing 108 Million

February 13, 2021 News /BioValleyBIOON/ -- At present, the COVID-19 epidemic overseas continues to spread rapidly. According to Baidu's "Real-time Epidemic Situation of Novel Coronavirus Pneumonia"Big DataReport》, as of 00:00 on February 13, 2021, the global cumulative confirmed cases exceeded 100 million (108 million), and deaths exceeded 2.38 million.

Recently, Junshi Biosciences (TopAlliance Biosciences) announced that its global partnerEli LillyPharmaceutical company (Eli Lilly) announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the investigational neutralizing antibody drug etesevimab (JS016 or LY-CoV016) 1400 mg and bamlanivimab (LY-CoV555) 700 mg dual-antibody therapy. This therapy is authorized for the treatment of patients aged 12 years and older with mild to moderate COVID-19 who are at risk of progressing to severe COVID-19 and/or hospitalization. Patients should receive the etesevimab and bamlanivimab dual-antibody therapy via a single intravenous infusion as soon as possible after being diagnosed with COVID-19 and within 10 days of symptom onset.

Furthermore,FDAThe infusion time for bamlanivimab monotherapy and the dual-antibody therapy of etesevimab and bamlanivimab has been approved to be shortened to 16 minutes and 21 minutes, respectively, significantly less than the previously approved 60-minute duration. This change responds to feedback from frontline nurses and physicians responsible for administering injections, aiming to alleviate the burden on the healthcare system.

This EUA is based on the Phase III BLAZE-1 study announced on January 26, 2021Clinical TrialsData showing that the dual-antibody therapy of etesevimab and bamlanivimab can reduce the risk of hospitalization and death from COVID-19 by 70%. These data, obtained from a larger patient population, corroborate the earlier results of the BLAZE-1 study published in the Journal of the American Medical Association (JAMA, IF=45.54). Compared with placebo, the most common adverse event reported by patients receiving the dual-antibody treatment of etesevimab and bamlanivimab was nausea on the day of infusion.

The Phase 2 and Phase 3 trials of the BLAZE-1 study evaluated a range of doses for bamlanivimab monotherapy and the combination therapy of etesevimab and bamlanivimab. The results demonstrated consistent and comparable clinical efficacy across these doses. Furthermore, preliminary results from the ongoing Phase 2 trial of the BLAZE-4 study provided viral load and pharmacodynamic/pharmacokinetic data, proving that the efficacy of the combination therapy with etesevimab 1400 mg and bamlanivimab 700 mg was similar to that of the combination therapy with etesevimab 2800 mg and bamlanivimab 2800 mg observed in the Phase 3 trial of the BLAZE-1 study. These data bolster confidence in the approved dosage, enhancing the accessibility of drug supply and helping more patients without compromising potential efficacy.

In the absence of other alternative drugs that have been approved and are available in sufficient supply,FDAProviding assistance through the granting of EUADiagnosisaccessibility of medicines for the treatment or prevention of potentially life-threatening diseases. The dual antibody therapy of etesevimab and bamlanivimab is authorized for use only during the authorization period, unless the authorization is terminated or withdrawn early. This authorization is for temporary use and does not replace formal evaluation and approval procedures. The dual antibody therapy of etesevimab and bamlanivimab remains an investigational drug and has not yet received approval under a Biologics License Application (BLA). Evaluation of its safety and efficacyClinical TrialStill ongoing; the relevant research data will be used to support future BLA submissions.

Bamlanivimab has been authorized in multiple countries, and the dual-antibody therapy of etesevimab and bamlanivimab has also been authorized in the United States and Italy. Eli Lilly will continue to collaborate with regulatory authorities worldwide to facilitate the global rollout of these therapies. To help as many patients as possible, Eli Lilly will continue to accelerate the production of etesevimab for global deployment. By mid-2021, Eli Lilly plans to partner with Amgen to produce up to 1 million doses of etesevimab for the dual-antibody therapy, with 100,000 doses ready imminently and an additional 150,000 doses scheduled for completion in the first quarter.Eli LillyThe procurement and distribution of the etesevimab and bamlanivimab dual-antibody therapy are expected to follow the same procedures as those for bamlanivimab monotherapy, with direct supply to governments to facilitate allocation based on unmet needs. The goal of global distribution is to ensure that patients with high unmet medical needs receive treatment, regardless of where they live.

Dr. Li Ning, CEO of Junshi Biosciences, stated: “From the initial launch of the collaborative development project on neutralizing antibodies by Junshi Biosciences and the Institute of Microbiology, Chinese Academy of Sciences at the outset of the pandemic, to our global partnersEli LillyWith its inclusion, this innovative therapy has now been authorized in the United States and Italy, and is gradually being deployed on a global scale. The collaborative innovation between domestic and overseas pharmaceutical professionals is dedicated to meeting the global demand for epidemic control. Relevant data on the dual-antibody therapy provide robust evidence for the safety and efficacy of JS016, bolstering our confidence in the ongoing clinical development of JS016 currently underway in mainland China, Hong Kong (China), the Philippines, and other countries and regions.Clinical Trial"Full of confidence."

Coronavirus Disease 2019 (COVID-19) is an acute respiratory infectious disease caused by the novel coronavirus (SARS-CoV-2). At the outset of the COVID-19 pandemic, Junshi Biosciences joined forces with the Institute of Microbiology, Chinese Academy of Sciences (IMCAS) to combat the epidemic, jointly developing the SARS-CoV-2 neutralizing antibody etesevimab (JS016 or LY-CoV016). Subsequently, Eli Lilly and Company licensed etesevimab from Junshi Biosciences, while Junshi Biosciences continued to lead development activities in the Greater China region.Eli LillyPharmaceutical companies lead development activities in other regions globally.

Etesevimab (JS016 or LY-CoV016) is a recombinant fully human monoclonal neutralizing antibody that specifically binds with high affinity to the receptor-binding domain (RBD) of the SARS-CoV-2 surface spike protein, effectively blocking the interaction between the virus and the host cell surface receptor ACE2. The development team introduced point mutations into the natural human IgG1 antibody framework to eliminate adverse effects such as tissue damage. A SARS-CoV-2 challenge study conducted in rhesus macaques demonstrated that etesevimab exhibits robust efficacy in both the prevention and treatment of SARS-CoV-2 infection.

Bamlanivimab (LY-CoV555) is a potent, neutralizing IgG1 monoclonal antibody targeting the SARS-CoV-2 spike protein. It was developed to block viral attachment and entry into human cells, thereby neutralizing the virus and potentially preventing and treating COVID-19. Bamlanivimab originated from a research collaboration between Eli Lilly and AbCellera to develop antibody therapies for the prevention and treatment of COVID-19. Following its discovery by AbCellera and testing by scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center, Eli Lilly scientists rapidly developed this antibody in less than three months. The antibody was identified from a blood sample collected from one of the first COVID-19 patients in the United States to recover from the disease. (Bioon.com)

Original source: Junshi Biosciences