WASHINGTON — The FDA issued an emergency use authorization (EUA) for bamlanivimab, an investigational monoclonal antibody, to treat patients with mild-to-moderate Covid-19 infection.
This EUA allows the experimental treatment to be used in any patients age 12 years or older weighing at least 40 kg who test positive for SARS-CoV-2 and are at high risk for progressing to severe Covid-19 or hospitalization. “This includes those who are 65 years of age or older, or who have certain chronic medical conditions,” the FDA noted.
Bamlanivimab — manufactured by Eli Lilly, otherwise known as LY-CoV555 — has suffered a series of setbacks recently, with a phase III trial of the treatment pausing temporarily in mid-October due to an unspecified safety concern and the phase III, NIAID-sponsored ACTIVE-3 trial testing the treatment in patients with severe disease shutting down permanently due to lack of efficacy.
Despite that, while the FDA noted that there is no proven benefit for bamlanivimab in hospitalized Covid-19 patients, the agency decided it has seen sufficient evidence to issue an EUA allowing the therapy to be distributed and administered as a single intravenous dose by health care providers.
“The FDA’s emergency authorization of bamlanivimab provides health care professionals on the frontline of this pandemic with another potential tool in treating Covid-19 patients,” said Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research, in a statement. “We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available.”
This EUA is based on data from an interim analysis of the phase II randomized, double-blind, placebo-controlled BLAZE-1 trial, the results of which were published in the New England Journal of Medicine at the end of October, as previously reported by BreakingMED.
Of the 465 non-hospitalized adults with mild-to-moderate Covid-19 symptoms who were included in the trial, “101 received a 700-milligram dose of bamlanivimab, 107 received a 2,800-milligram dose, 101 received a 7,000-milligram dose and 156 received a placebo within three days of obtaining the clinical sample for the first positive SARS-CoV-2 viral test,” the FDA explained.
“The pre-specified primary endpoint in the phase two trial was change in viral load from baseline to day 11 for bamlanivimab versus placebo,” the agency wrote. “Most patients, including those receiving placebo, cleared the virus by day 11. However, the most important evidence that bamlanivimab may be effective came from the predefined secondary endpoint of Covid-19-related 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. The effects on viral load and on reduction in hospitalizations and ER visits, and on safety, were similar in patients receiving any of the three bamlanivimab doses.”
The FDA noted that there are “no adequate, approved, and available alternative treatments to bamlanivimab for the authorized population.” Under this EUA, Eli Lilly is required to implement several quality measures while manufacturing bamlanivimab. The therapy is also required to come with fact sheets for health care providers and patients/caregivers with information about using bamlanivimab to treat patients with Covid-19, including dosing instructions, potential side effects, and possible drug interactions.
Potential side effects of bamlanivimab include anaphylaxis and infusion-related reactions, nausea, diarrhea, dizziness, headache, itching, and vomiting, the agency warned.
John McKenna, Associate Editor, BreakingMED™
Cat ID: 151
Topic ID: 88,151,730,933,190,926,192,927,151,725,928,925,934