Patient support

Primary immunobridging results against JN.1 in Cohort A

Immunobridging is based on the serum neutralization titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2. This includes adintrevimab, the parent mAb of pemivibart, and other mAbs that were previously authorized for Emergency Use Authorization (EUA). To support immunobridging, serum neutralization titer was utilized to compare PEMGARDA® to previous mAbs.1

Immunobridging would be established if the lower limit of the 2-sided 90% CI of the ratio of the geometric mean titer value is greater than 0.8.1

 Immunobridging method 11

PEMGARDA neutralizing antibody titers were compared to historical titers of the reference monoclonal antibody adintrevimab

The geometric mean ratio between the calculated titer for PEMGARDA against JN.1 (based on a pseudotyped VLP neutralization assay EC50 value of 74.6 ng/mL) and the calculated titer for adintrevimab against Delta (based on an authentic virus neutralization assay EC50 value of 7 ng/mL) was 0.70 (90% CI: 0.68-0.72).

 Immunobridging method 21

PEMGARDA neutralizing antibody titers were compared to the titers of 3 reference monoclonal antibodies with clinical efficacy against mild-to-moderate COVID-19

The range of titers achieved with PEMGARDA for 3 months following administration of 4500 mg IV were consistent with the titer levels associated with clinical efficacy in prior clinical trials evaluating certain monoclonal antibodies for the prevention of COVID-19.

COHORT A RESULTS

Exploratory clinical efficacy results

Exploratory objectives of CANOPY evaluated rates of RT-PCR–confirmed COVID-19, COVID-19–related hospitalizations, or all-cause death 
in participants in both cohorts.1

In Cohort A (adults with moderate-to-severe immune compromise), no COVID-19–related hospitalizations occurred through Month 6.
Two all-cause deaths (one due to an unknown cause and one due to suicide) occurred through Month 6.1

Time to event (RT-PCR–confirmed symptomatic COVID-19) analysis Cohort A2,*
*Cumulative incidence of RT-PCR–confirmed COVID-19, COVID-19–related hospitalization, and all-cause mortality through day 180 for Cohort A, the full analysis set. Participants who did not have the defined event on or before the above censoring date were censored at the earliest of the end-of-study date, 180-day follow-up, date of participant’s receipt of COVID-19 vaccine, or analysis cutoff date. One participant in Cohort A who received a postdose COVID-19 vaccine was censored at the time of vaccination.
COHORT B RESULTS

Exploratory clinical efficacy results through Month 3

In Cohort B (adults without moderate-to-severe immune compromise), most infection events occurred during a period of time when JN.1 and 
variants with similar susceptibilities were dominant. No deaths or COVID-19–related hospitalizations occurred in either treatment arm of Cohort B through Month 6.1

PEMGARDA is not authorized for use in individuals who do not have moderate-to-severe immune compromise.1

RT-PCR–confirmed symptomatic COVID-19, COVID-19–related
hospitalizations, or all-cause death† through Month 31,‡
†No COVID-19–related hospitalizations or deaths occurred in either treatment arm of Cohort B through Month 3.
‡Following the initial dosing period of the trial.1

Exploratory clinical efficacy results through Month 6

RT-PCR–confirmed symptomatic COVID-19, COVID-19–related
hospitalizations, or all-cause death† through Month 61,§
†No COVID-19–related hospitalizations or deaths occurred in either treatment arm of Cohort B through Month 6.
§Cumulative through Month 6, following the initial dosing and redosing periods of the trial.1

PEMGARDA is available

Be prepared to help prevent COVID-19 in your moderately to severely immunocompromised patients with PEMGARDA.

Order now
Expand

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.
Expand

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. Wolfe CR, Cohen J, Mahoney K, et al. Safety and efficacy of pemivibart, a long-acting monoclonal antibody, for prevention of symptomatic COVID-19: interim results from a phase 3 randomized clinical trial (CANOPY). Clin Infect Dis. Published online May 24, 2025. doi:10.1093/cid/ciaf265