Bamlanivimab (Page 11 of 12)

18.2 Post-Exposure Prophylaxis of COVID-19 (BLAZE-2)

The data supporting this EUA for post-exposure prophylaxis of COVID-19 are based on the final analysis of Part 1 of the Phase 3 trial BLAZE-2 (NCT04497987). The database lock occurred after all enrolled subjects completed Day 57. BLAZE-2 Part 1 is a randomized, double-blind, placebo-controlled study evaluating bamlanivimab alone for prevention of COVID-19 in residents and staff of skilled nursing facilities following a confirmed reported case of SARS-CoV-2 infection at the facility. No pediatric participants were enrolled.

All participants in Part 1 were randomized and treated with a single infusion of bamlanivimab 4,200 mg or placebo. Results of baseline testing for SARS-CoV-2 were not known until after the therapy was administered. Those with a positive baseline SARS-CoV-2 RT-PCR test were included in the Treatment Population (N=132) and those with a negative test were included in the Prevention Population (N=966). Individuals in these populations were also required to have a baseline negative SARS-CoV-2 serology test; those who tested positive were only included in the overall safety population.

Data are presented for the Prevention Population only. No data were collected on the type or extent of exposure to the index case in the Prevention Population.

In the overall Prevention Population (N=484 for bamlanivimab 4,200 mg and N=482 for placebo) at baseline, the median age was 53 years (with 29% of subjects aged 65 or older); 75% of subjects were female, 89% were White, 5% were Hispanic or Latino, and 8% were Black. The baseline demographics and disease characteristics were well balanced across bamlanivimab and placebo treatment groups.

The primary endpoint (cases of symptomatic COVID-19 by Day 57) was assessed after all participants in the Prevention Population reached 8 weeks of follow-up, and analysis were adjusted for facility, sex, and role within facility (resident/staff). There were 114 cases of symptomatic COVID-19, with a lower frequency occurring in participants treated with bamlanivimab as compared to placebo (residents and staff; adjusted odds ratio 0.43; p<0.001) reducing the risk of being infected with COVID-19 by up to 57%. As a supplementary analysis, the time to symptomatic COVID-19 is shown for each arm in Figure 2. Four COVID-19-related deaths were reported in the overall Prevention Population; all occurred in the placebo arm (0.8%). No COVID-19-related deaths occurred in the bamlanivimab arm.

Figure 2: Time to symptomatic COVID-19 in the overall prevention population (residents and staff).

For the pre-specified subgroup of nursing home residents, there were 45 cases of symptomatic COVID-19, with a lower frequency in those treated with bamlanivimab versus placebo (adjusted odds ratio 0.20; p<0.001), reducing the risk of being infected with COVID-19 by up to 80%. The time to symptomatic COVID-19 in nursing home residents is shown by treatment arm in Figure 3. In this same cohort of residents within the Prevention Population, 6 deaths due to any cause occurred in residents treated with placebo (4.3%) and 5 deaths due to any cause occurred in residents treated with bamlanivimab (3.1%).

Figure 3: Time to symptomatic COVID-19 in residents only.

For the post-hoc subgroup of patients who met the high risk criteria (all residents and all high risk staff 7), there were 75 cases of symptomatic COVID-19, with a lower frequency in those treated with bamlanivimab versus placebo (adjusted odds ratio 0.28; nominal p<0.001), reducing the risk of being infected with COVID-19 by up to 72%.

For the post-hoc subgroup of staff who did not meet high risk criteria, there were 39 cases of symptomatic COVID-19, with less evidence of a preventative effect for bamlanivimab versus placebo (adjusted odds ratio 0.64; nominal p=0.26).

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7

All high risk participants in the Prevention Population were either residents in a skilled nursing or assisted living facility, or staff in a skilled nursing or assisted living facility who satisfied at least 1 of the following at the time of screening: were ≥65 years of age, had a BMI ≥35, had CKD, had diabetes, had immunosuppressive disease, were currently receiving immunosuppressive treatment, OR were ≥55 years of age AND had cardiovascular disease, OR hypertension, OR COPD or other chronic respiratory disease.

19 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

UNDER THIS EUA, BAMLANIVIMAB AND ETESEVIMAB MUST BE ADMINISTERED TOGETHER.

Bamlanivimab

Bamlanivimab injection is a sterile, preservative-free clear to opalescent and colorless to slightly yellow to slightly brown solution supplied in a vial.

Etesevimab

Etesevimab injection is a sterile, preservative-free clear to opalescent and colorless to slightly yellow to slightly brown solution supplied in a vial.

Bamlanivimab and etesevimab are supplied as:

Antibody	Concentration	Package Size	NDC
Bamlanivimab	700 mg/20 mL (35 mg/mL)	one vialper carton	0002-7910-01
Etesevimab	700 mg/20 mL (35 mg/mL)	one vialper carton	0002-7950-01

Storage and Handling

Bamlanivimab is preservative-free. Discard unused portion.

Etesevimab is preservative-free. Discard unused portion.

Store unopened vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.

FDA has authorized an extension to the shelf-life (i.e., expiration date) of both bamlanivimab and etesevimab following a thorough review of data submitted by Eli Lilly and Company. The extension applies to all unopened vials of bamlanivimab and etesevimab that have been held in accordance with storage conditions. Confirm the shelf-life of unopened vials of bamlanivimab and etesevimab by batch number at the FDA EUA website under the Drug and Biological Therapeutic Products bamlanivimab and etesevimab. This site includes a complete listing of extended expiration dates by batch number. If the batch number on the vial/carton is not included in this listing, the product is labeled with the correct expiration date.

DO NOT FREEZE, SHAKE, OR EXPOSE TO DIRECT LIGHT.

The prepared infusion solution is intended to be used immediately. If immediate administration is not possible, store infusion solution in the refrigerator at 2°C to 8°C (36°F to 46°F) for up to 24 hours and at room temperature (20°C to 25°C [68°F to 77°F]) and for up to 7 hours, including infusion time. If refrigerated, allow the infusion solution to equilibrate to room temperature prior to administration.

20 PATIENT COUNSELING INFORMATION

Patients treated with bamlanivimab and etesevimab should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect “high touch” surfaces, and frequent handwashing) according to CDC guidelines. Also see Fact Sheet for Patients, Parents and Caregivers.