Update: Eli Lilly’s Anti-COVID Product Approved by FDA

Patients at high risk—older people and people with comorbidities—for coronavirus disease 2019 (COVID-19) can now turn to a treatment given emergency use authorization (EUA) by the US Food and Drug Administration yesterday.

In a press release, Eli Lilly said that bamlanivimab, a monoclonal antibody, can be used for anyone 65 or older. Those with comorbidities who are 12 and older who have an underlying health condition can also use the product if they have been diagnosed with mild-to-moderate COVID-19. However, the EUA doesn’t approve the use of bamlanivimab for hospitalized patients nor for those who require oxygen because of COVID-19. In those cases, bamlanivimab could worsen clinical outcomes.

Speed is an important factor when administering bamlanivimab, the company says. The therapy should be administered via a single intravenous infusion as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.

The company’s chairman and CEO, David A. Ricks, said in the press release that “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.”

What sealed the EUA was data demonstrating that a one-time infusion of bamlanivimab reduced the need for hospitalization and visits to the emergency room for patients at high-risk for COVID-19.

“The EUA is based on data from BLAZE-1, a randomized, double-blind, placebo-controlled Phase 2 study in patients with recently diagnosed mild to moderate COVID-19 in the outpatient setting,” the press release states. “Patients treated with bamlanivimab showed reduced viral load and rates of symptoms and hospitalization. In BLAZE-1, frequency and types of adverse events were similar between bamlanivimab and placebo, with the majority being mild to moderate in severity. Infusion reactions and other allergic hypersensitivity events have been reported. The EUA includes a warning for hypersensitivity including anaphylaxis and infusion-related reactions.”

Eli Lilly plans to begin shipping bamlanivimab via the distributor AmerisourceBergen. However, regional allocations will be determined by the federal government, which has purchased 300,000 doses of the treatment. And, as mandated by the government, Americans will not have to pay for the medicine, although hospitals and other healthcare facilities may charge for providing bamlanivimab.

Daniel Skovronsky, MD, PhD, Lilly’s chief scientific officer and president of Lilly Research Laboratories, said in the press release that “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. We thank those who have contributed to this medical advancement, particularly the clinical trial investigators and participants around the country.”

The company plans to produce one million doses of the monoclonal antibody by the end of this year. Those doses will be available globally. The company expects that the supply will increase dramatically next year. An independent third party will review records and other data about bamlanivimab.

Another potential future product is composed of LY-CoV555 and LY-CoV016 antibodies. Both products in previous reports had spectacular results. The combination product, having two different antibodies, would be expected to be less susceptible to the development of resistance. So far, Eli Lilli has not observed the development of resistant variants using the combination product.

Eli Lilly stated the combination product had no drug related serious adverse events. The LY-CoV555 monoclonal antibody was “well tolerated” without the observation of any drug-related serious events. But it did have “isolated drug-related infusion reactions or hypersensitivity,” two of which were reported as “serious reactions” with all patients recovering. Both products had adverse events were similar to placebo.

Eli Lilly has also observed that most hospitalizations occurred in patients who had an increased age or BMI. Underscoring the importance of the co-morbidities of age and obesity in COVID-19 disease.

A related product, convalescent serum, was found to have clinical efficacy when it was given within three days of diagnosis and in high concentration. And although given an FDA emergency authorization, its overall benefit has since been panned in the news media.

One may ask, why are the Eli Lilly results different from the positive but somewhat disappointing results of convalescent serum? The short answer is, they are not. Both monoclonal antibodies target the same clinical sweet spot where convalescent serum was found to be most effective.