Lilly Gets EUA for Covid Antibody Treatment

FDA has issued Eli Lilly an emergency use authorization (EUA) for its investigational monoclonal antibody therapy bamlanivimab for treating mild-to-moderate Covid-19 in adult and pediatric patients. The therapy is authorized for patients 12 years of age and older weighing at least 40 kilograms (about 88 pounds), and who are at high risk for progressing to severe Covid-19 or hospitalization. “While the safety and effectiveness of this investigational therapy continues to be evaluated, bamlanivimab was shown in clinical trials to reduce Covid-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo,” an agency release says.

The EUA presumably and indirectly addresses whether Lilly has demonstrated to FDA that it has control of quality at the company’s bamlanivimab active pharmaceutical ingredient plant in Branchburg, NJ following two recent FDA inspections that cited GMP deficiencies (see earlier story). A recently-posted Form FDA-483 issued after an August reinspection at the company’s Imclone manufacturing facility found that incidents during GMP activities that may have affected product quality were not investigated. In response, a Lilly statement said the company is “working diligently to address a total of four FDA observations from the inspections and [we] have performed in-depth investigations into each of the FDA’s areas of concern. For each observation, Lilly has either completed its remediation activities or has put enhanced interim controls in place while our improvements are completed. In each case, we have confirmed that there was never an impact on product quality.”

FDA says bamlanivimab is not authorized for patients who are hospitalized or require oxygen therapy due to Covid-19 because a benefit for them has not been shown, it says. “Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients with Covid-19 requiring high flow oxygen or mechanical ventilation.”

The EUA was based on data examining hospitalizations or emergency room visits within 28 days after treatment. “For patients at high risk for disease progression, hospitalizations and emergency room visits occurred in 3% of bamlanivimab-treated patients on average compared to 10% in placebo-treated patients,” FDA says.