- Eli Lilly and UnitedHealth Group said Friday they're putting together a study of potentially up to half a million people that will try to suss out the most effective ways for using and administering Lilly's recently authorized COVID-19 drug.
- Last month, the drug, an engineered antibody called bamlanivimab, was cleared for emergency use in patients with mild to moderate COVID-19 who are at high risk of progressing to severe disease or being hospitalized. While antibody drugs are seen as potentially valuable treatments options, especially in the absence of an approved vaccine, it remains unclear how useful they will be outside the confines of a controlled clinical trial.
- Lilly and UnitedHealth are trying to shed light on that issue with their study, which will invite UnitedHealthcare Medicare Advantage members who meet certain criteria to enroll. Those who opt in will download a symptom-checking app and complete a daily questionnaire, and if they report COVID-19 symptoms, they'll be sent an in-home SARS-CoV-2 test that they'll self-administer and return. Participants who test positive will then be contacted by a UnitedHealth nurse to schedule a home infusion treatment of bamlanivimab.
Globally, the number of confirmed coronavirus infections has surged past 65 million, while the number of deaths is at least 1.5 million. Though an effective vaccine still represents the best shot at ending the pandemic, the urgent need for treatments has pushed drug developers to work toward therapies that can help infected patients recover faster, keep them out of the hospital, or spare them of life-threatening symptoms.
Lilly is one of the companies that chose to focus its efforts on antibody drugs like bamlanivimab, which is supposed to block the docking station through which SARS-CoV-2 infiltrates human cells. Clinical studies of Lilly's drug, as well as a high-profile antibody treatment from Regeneron that was used to treat President Donald Trump, have suggested these kinds of medicines can at least help patients with mild COVID-19 cases.
Still, it's not entirely clear how useful antibody drugs will ultimately be in the fight against the pandemic. Researchers recently determined Lilly's drug, for example, isn't very helpful in COVID-19 patients who have been hospitalized. It's logistically complex to ensure the right patients will get treated at the right time, before their disease progresses.
Antibody drugs can also be challenging to administer, relying on effective screening procedures and then specific healthcare settings where the patient can receive an infusion without risking infecting others. And with cases soaring in the U.S. and elsewhere, Lilly and Regeneron don't yet have enough product to meet demand. Both expect manufacturing capacity to ramp up considerably next year.
The hope for Lilly and UnitedHealth is that their new partnership, which marries one of the world's largest drugmakers with one of the world's biggest managed health care companies, will provide much-need solutions to some of these lingering problems.
"While bamlanivimab is authorized for emergency use based on the efficacy and safety data accumulated to date, larger pragmatic studies in diverse populations can help us further understand the efficacy and safety of SARS-CoV-2 neutralizing antibodies in real world settings," said Daniel Skovronsky, Lilly's chief scientific officer, in a Dec. 4 statement.