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CANOPY trial design1,2

The CANOPY Phase 3 clinical trial studied the efficacy and safety of a single dose of PEMGARDA® 4500 mg for the pre-exposure prophylaxis of COVID-19 in adults ≥18 years of age in 2 cohorts.1

All participants in Cohort A had underlying moderate-to-severe immune compromise.1

sVNA, serum virus neutralizing antibody.
Tap to enlarge Cohort information
Timeline of results1,2
Ratio of the geometric mean titers between PEMGARDA against the relevant variant (JN.1) and the reference titer against the Delta variant (B.1.617.2)
RT-PCR–confirmed symptomatic COVID-19, COVID-19–related hospitalization, or all-cause death through Month 3
RT-PCR–confirmed symptomatic COVID-19, COVID-19–related hospitalization, or all-cause death through Month 6
 
RT-PCR, reverse transcription-polymerase chain reaction.
Inclusion criteria2
  • Adults aged ≥18 years weighing ≥40 kg at time of screening
  • Tests negative for current SARS-CoV-2 infection by local antigen test or RT-PCR at time of screening
  • For Cohort A: Has significant immune compromise from causes including solid tumor or hematologic malignancies, CAR-T-cell therapy or HSCT, primary immunodeficiency, advanced HIV infection, or receiving qualifying immunosuppressive therapies
  • For Cohort B: Is at risk of acquiring SARS-CoV-2 due to regular unmasked face-to-face interactions in indoor settings
  • Defers receipt of any COVID-19 vaccination/booster for ≥28 days after dosing on Day 1
  • Note: Unless specified by Cohort, the criteria applied to both Cohorts
HSCT, hematopoietic stem cell transplantation.
Exclusion criteria2
  • For Cohort B: Prior receipt of a COVID-19 vaccine or booster within 120 days before randomization
  • Prior receipt of convalescent plasma or a mAb to SARS-CoV-2 active against currently circulating variants, including in the setting of a clinical trial, within 120 days before randomization
  • Prior known or suspected SARS-CoV-2 infection within 120 days before randomization
  • Exposure to someone with known or suspected SARS-CoV-2 infection in the 5 days before randomization
  • Is acutely ill or has any symptoms suggestive of infection, in the opinion of the investigator

CANOPY trial objectives

Cohort A
(moderate-to-severe immune compromise)1

COHORT A primary efficacy objective: Evaluate protection against symptomatic COVID-19 based on calculated titers against SARS-CoV-2 following PEMGARDA administration by immunobridging to historical data from the EVADE study, which provided evidence of clinical efficacy of adintrevimab, the parent mAb of PEMGARDA.

COHORT A exploratory objective: Collect data on RT-PCR–confirmed COVID-19, COVID-19–related hospitalizations, or all-cause death in participants who received a full initial dose of study drug.

Cohort B
(without moderate-to-severe immune compromise)1

COHORT B exploratory efficacy objective: Evaluate clinical efficacy of PEMGARDA compared to placebo in the prevention of RT-PCR–confirmed COVID-19 in randomized participants without SARS-CoV-2 infection at baseline and without moderate-to-severe immune compromise.

Primary safety objective of both cohorts2: Evaluate the safety and tolerability of PEMGARDA in all treated participants.

Cohort A patient characteristics

Participants included in Cohort A of the CANOPY trial were classified

as moderately to severely immunocompromised1
Actor portrayal.

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WARNING: ANAPHYLAXIS

  • Anaphylaxis has been observed with PEMGARDA in 0.6% (4/623) of participants in a clinical trial.
  • Anaphylaxis was reported during the first and second infusion of PEMGARDA.
  • Anaphylaxis can be life-threatening.
  • Prior to administering PEMGARDA, consider the potential benefit of COVID-19 prevention along with the risk of anaphylaxis.
  • Administer PEMGARDA only in settings in which healthcare providers have immediate access to medications to treat anaphylaxis and the ability to activate the emergency medical system (EMS), as necessary.
  • Clinically monitor individuals during the infusion and for at least two hours after completion of the infusion.
  • Discontinue PEMGARDA use permanently if signs or symptoms of anaphylaxis or any severe systemic reaction are observed and initiate appropriate medications and/or supportive therapy.
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WARNING: ANAPHYLAXIS

  • Anaphylaxis has been observed with PEMGARDA in 0.6% (4/623) of participants in a clinical trial.
  • Anaphylaxis was reported during the first and second infusion of PEMGARDA.
  • Anaphylaxis can be life-threatening.
  • Prior to administering PEMGARDA, consider the potential benefit of COVID-19 prevention along with the risk of anaphylaxis.
  • Administer PEMGARDA only in settings in which healthcare providers have immediate access to medications to treat anaphylaxis and the ability to activate the emergency medical system (EMS), as necessary.
  • Clinically monitor individuals during the infusion and for at least two hours after completion of the infusion.
  • Discontinue PEMGARDA use permanently if signs or symptoms of anaphylaxis or any severe systemic reaction are observed and initiate appropriate medications and/or supportive therapy.

EMERGENCY USE AUTHORIZATION (EUA) FOR PEMGARDA®

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PEMGARDA for the pre-exposure prophylaxis of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg):

  • Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and
  • Who have moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and are unlikely to mount an adequate response to COVID-19 vaccination.

Limitations OF AUTHORIZED USE

  • PEMGARDA is not authorized for use for treatment of COVID-19, or for post-exposure prophylaxis of COVID-19 in individuals who have been exposed to someone infected with SARS-CoV-2.
  • PEMGARDA is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is less than or equal to 90% based on available information including variant susceptibility to PEMGARDA and national variant frequencies.
  • Pre-exposure prophylaxis with PEMGARDA is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Individuals for whom COVID-19 vaccination is recommended, including individuals with moderate-to-severe immune compromise who may derive benefit from COVID-19 vaccination, should receive COVID-19 vaccination.
  • In individuals who have recently received a COVID-19 vaccine, PEMGARDA should be administered at least 2 weeks after vaccination.

PEMGARDA may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs.

PEMGARDA has been authorized by FDA for the emergency use described above. It is not FDA-approved for any use, including use for pre-exposure prophylaxis of COVID-19.

PEMGARDA is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PEMGARDA under Section 564(b)(1) of the FD&C Act, 21 U.S.C. § 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner.

IMPORTANT SAFETY INFORMATION

PEMGARDA is contraindicated in individuals with previous severe hypersensitivity reactions, including anaphylaxis, to any component of PEMGARDA.

Serious hypersensitivity reactions, including anaphylaxis, and infusion-related reactions can occur during the infusion and up to 24 hours after the infusion of PEMGARDA and may be severe or life threatening. If signs and symptoms of a clinically significant hypersensitivity reaction or infusion-related reaction occur, immediately discontinue administration, and initiate appropriate medications and/or supportive therapy. Permanently discontinue PEMGARDA in individuals who experience signs or symptoms of anaphylaxis.

PEMGARDA contains polysorbate 80, which is in some COVID-19 vaccines and is structurally similar to polyethylene glycol (PEG), an ingredient in other COVID-19 vaccines. For individuals with a history of severe hypersensitivity reaction to a COVID-19 vaccine, consider consultation with an allergist-immunologist prior to PEMGARDA administration.

Certain SARS-CoV-2 viral variants may emerge that have substantially reduced susceptibility to PEMGARDA. PEMGARDA may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants. Inform individuals of the increased risk, compared to other variants, for COVID-19 due to SARS-CoV-2 viral variants that exhibit significantly reduced susceptibility to PEMGARDA. If signs and symptoms of COVID-19 occur, advise individuals to test for COVID-19 and seek medical attention, including starting treatment for COVID-19 as appropriate.

The most common adverse events (all grades, incidence ≥2% and greater than placebo, through Month 6) observed in participants who have moderate-to-severe immune compromise in Cohort A PEMGARDA included systemic and local infusion-related or hypersensitivity reactions, viral infection, upper respiratory tract infection, influenza-like illness, urinary tract infection, fatigue, headache, sinusitis, nasopharyngitis, influenza and pneumonia.

The most common adverse events (all grades, incidence ≥2% and greater than placebo, through Month 6) observed in participants who do not have moderate-to-severe immune compromise in Cohort B treated with PEMGARDA included systemic and local infusion-related or hypersensitivity reactions, upper respiratory tract infection, viral infection, influenza-like illness, enterovirus infection, and viral upper respiratory tract infection.

PEMGARDA should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

Maternal IgG is known to be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PEMGARDA and any potential adverse effects on the breastfed infant from PEMGARDA.

The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all serious adverse events and medication errors potentially related to PEMGARDA within 7 calendar days from the healthcare provider’s awareness of the event. See Section 6.4 of the accompanying Fact Sheet for more information.

Complete and submit the report online: https://www.fda.gov/medwatch/report.htm. See Section 6.4 of the Fact Sheet for additional mechanisms for reporting.

See Fact Sheet for Healthcare Providers and FDA Letter of Authorization.

References: 1. PEMGARDA Fact Sheet for healthcare providers. Waltham, MA; Invivyd, Inc. 2. Data on file. Invivyd, Inc. Waltham, MA.