Lilly’s Covid-19 candidate bamlanivimab gets FDA’s EUA

The US Food and Drug Administration (FDA) has issued emergency use authorization (EUA) for bamlanivimab (LY-CoV555) 700 mg, the investigational neutralizing antibody of Eli Lilly and Company (Lilly) for the treatment of mild to moderate Covid-19.

Bamlanivimab has been authorized to be used in adults and pediatric patients, aged 12 years and older with a positive test result, who are at high risk for progressing to severe infection and/or hospitalization.

The investigational neutralizing antibody has to be given as soon as possible after a positive Covid-19 test and within 10 days of the onset of symptoms.

The FDA EUA for bamlanivimab enables its distribution and emergency use. The investigational drug has to be given through a single intravenous infusion.

David A. Ricks – Lilly chairman and CEO said: “This emergency authorization allows us to make bamlanivimab available as a COVID-19 treatment for recently diagnosed, high-risk patients – adding a valuable tool for doctors fighting the now-increasing burden of this global pandemic.

“The rapid development and availability of bamlanivimab could not have been achieved without the relentless work of our Lilly team, collaboration across the industry and the urgent work being done by the government to ensure appropriate allocation to patients who need it the most.”

Lilly’s Covid-19 candidate bamlanivimab gets FDA’s emergency use authorization. Photo courtesy of Momoneymoproblemz/Wikipedia.org.

The FDA EUA for bamlanivimab has been granted based on the findings of the phase 2 BLAZE-1 trial in patients with recently diagnosed mild to moderate Covid-19 in the outpatient setting.

Patients, who received bamlanivimab showed lowered viral load and rates of symptoms and hospitalization. In the mid-stage trial, the frequency and types of adverse events associated with bamlanivimab were similar to placebo, with the majority being mild to moderate in severity.

Daniel Skovronsky – Lilly chief scientific officer and president of Lilly Research Laboratories said: “The BLAZE-1 data show bamlanivimab, when given early in the disease course, may help patients clear the virus and reduce COVID-related hospitalizations, supporting our belief that neutralizing antibodies can be an important therapeutic option for patients fighting this virus.

“We’re proud of the speed with which we have been able to bring patients this therapy specifically designed to treat COVID-19.”

In late October, Lilly signed a deal worth $375 million with the US government for supplying 300,000 vials of bamlanivimab 700mg. Lilly will immediately start shipping bamlanivimab to AmerisourceBergen, a national distributor, which will distribute it as per the allocation program of US government.