Invivyd at the Ready for Upcoming Respiratory Virus Season with PEMGARDA™ (pemivibart) to Help Protect Vulnerable Immunocompromised Persons from COVID-19
Invivyd, Inc. (Nasdaq: IVVD) announces readiness to address the increasing COVID-19 cases with PEMGARDA™ (pemivibart), an FDA-authorized monoclonal antibody for pre-exposure prophylaxis in certain immunocompromised individuals. The CDC reports a continued rise in COVID-19 death rates throughout 2024, with immunocompromised patients at highest risk. PEMGARDA is covered by Medicare and Medicaid and has gained rapid commercial coverage across major health plans.
The Infectious Disease Society of America recommends PEMGARDA for PrEP in moderately to severely immunocompromised adults and adolescents at risk of severe COVID-19. Invivyd has launched a Patient Savings Program to assist eligible commercially insured patients. Recent data shows PEMGARDA's continued neutralizing activity against dominant SARS-CoV-2 variants KP.3.1.1 and LB.1. Invivyd is also developing VYD2311, a next-generation mAb candidate with promising early results.
Invivyd, Inc. (Nasdaq: IVVD) annuncia la sua disponibilità a fronteggiare l'aumento dei casi di COVID-19 con PEMGARDA™ (pemivibart), un anticorpo monoclonale autorizzato dalla FDA per la profilassi pre-esposizione in determinati individui immunocompromessi. I rapporti del CDC evidenziano un continuo aumento dei tassi di mortalità per COVID-19 durante il 2024, con pazienti immunocompromessi a maggior rischio. PEMGARDA è coperto da Medicare e Medicaid e ha ottenuto rapidamente una copertura commerciale attraverso i principali piani sanitari.
La Società delle Malattie Infettive d'America raccomanda PEMGARDA per la PrEP in adulti e adolescenti moderatamente a gravemente immunocompromessi a rischio di COVID-19 severo. Invivyd ha lanciato un Programma di Risparmio per i Pazienti per assistere i pazienti commercialmente assicurati idonei. Dati recenti mostrano l'attività neutralizzante continua di PEMGARDA contro le varianti dominanti del SARS-CoV-2 KP.3.1.1 e LB.1. Invivyd sta anche sviluppando VYD2311, un candidato mAb di nuova generazione con risultati preliminari promettenti.
Invivyd, Inc. (Nasdaq: IVVD) anuncia su disposición para abordar el aumento de casos de COVID-19 con PEMGARDA™ (pemivibart), un anticuerpo monoclonal autorizado por la FDA para la profilaxis de preexposición en ciertos individuos inmunocomprometidos. Los informes de los CDC muestran un aumento continuo en las tasas de mortalidad por COVID-19 a lo largo de 2024, siendo los pacientes inmunocomprometidos los de mayor riesgo. PEMGARDA está cubierto por Medicare y Medicaid y ha obtenido una rápida cobertura comercial a través de los principales planes de salud.
La Sociedad de Enfermedades Infecciosas de América recomienda PEMGARDA para PrEP en adultos y adolescentes moderadamente a gravemente inmunocomprometidos en riesgo de COVID-19 severo. Invivyd ha lanzado un Programa de Ahorros para Pacientes para ayudar a los pacientes comercialmente asegurados elegibles. Datos recientes muestran la actividad neutralizante continua de PEMGARDA contra las variantes dominantes del SARS-CoV-2 KP.3.1.1 y LB.1. Invivyd también está desarrollando VYD2311, un candidato de mAb de próxima generación con resultados iniciales prometedores.
Invivyd, Inc. (Nasdaq: IVVD)는 특정 면역 저하 환자를 위한 사전 노출 예방 목적으로 FDA에서 승인된 단클론 항체인 PEMGARDA™ (pemivibart)로 COVID-19 사례 증가에 대응할 준비가 되었다고 발표했습니다. CDC는 2024년 내내 COVID-19 사망률이 계속 증가하고 있으며, 면역 저하 환자가 가장 높은 위험에 처해 있다고 보고하고 있습니다. PEMGARDA는 메디케어와 메디케이드에 의해 보장됩니다며 주요 건강 보험 계획에서 신속한 상업적 보장을 확보했습니다.
미국 감염병학회는 중등도에서 중증으로 면역 저하된 성인 및 청소년이 심각한 COVID-19에 위험이 있는 경우 PEMGARDA를 PrEP로 추천합니다. Invivyd는 적격 상업적 보험 가입자를 지원하기 위해 환자 절약 프로그램을 시작했습니다. 최근 데이터는 PEMGARDA가 지배적인 SARS-CoV-2 변종 KP.3.1.1 및 LB.1에 대해 지속적인 중화 작용을 유지하고 있음을 보여줍니다. Invivyd는 또한 유망한 초기 결과를 가진 차세대 mAb 후보인 VYD2311을 개발하고 있습니다.
Invivyd, Inc. (Nasdaq: IVVD) annonce sa disponibilité pour faire face à l'augmentation des cas de COVID-19 avec PEMGARDA™ (pemivibart), un anticorps monoclonal autorisé par la FDA pour la prophylaxie pré-exposition chez certains individus immunodéprimés. Les rapports des CDC montrent une augmentation continue des taux de mortalité liés au COVID-19 tout au long de 2024, les patients immunodéprimés étant les plus à risque. PEMGARDA est couvert par Medicare et Medicaid et a rapidement obtenu une couverture commerciale auprès des principaux régimes de santé.
La Société des Maladies Infectieuses d'Amérique recommande PEMGARDA pour la PrEP chez les adultes et adolescents modérément à sévèrement immunodéprimés à risque de COVID-19 sévère. Invivyd a lancé un Programme d'Économie pour les Patients pour aider les patients éligibles ayant une assurance commerciale. Des données récentes montrent que PEMGARDA continue de présenter une activité neutralisante contre les variants dominants du SARS-CoV-2 KP.3.1.1 et LB.1. Invivyd développe également VYD2311, un candidat mAb de nouvelle génération avec des résultats préliminaires prometteurs.
Invivyd, Inc. (Nasdaq: IVVD) gibt seine Bereitschaft bekannt, auf die steigenden COVID-19-Fälle mit PEMGARDA™ (pemivibart) zu reagieren, einem von der FDA autorisierten monoklonalen Antikörper zur präexpositionellen Prophylaxe bei bestimmten immungeschwächten Personen. Die CDC berichtet von einem kontinuierlichen Anstieg der COVID-19-Todesfälle im Jahr 2024, wobei immun Geschwächte Patienten das höchste Risiko haben. PEMGARDA ist von Medicare und Medicaid abgedeckt und hat schnell kommerzielle Abdeckung durch große Gesundheitspläne erhalten.
Die Infectious Disease Society of America empfiehlt PEMGARDA als PrEP für mäßig bis schwer immungeschwächte Erwachsene und Jugendliche, die ein Risiko für schwere COVID-19 haben. Invivyd hat ein Patienten-Ersparnisprogramm ins Leben gerufen, um berechtigten kommerziell versicherten Patienten zu helfen. Neue Daten zeigen die anhaltende neutralisierende Aktivität von PEMGARDA gegen die dominierenden SARS-CoV-2-Varianten KP.3.1.1 und LB.1. Invivyd entwickelt außerdem VYD2311, einen vielversprechenden mAb-Kandidaten der nächsten Generation mit vielversprechenden frühen Ergebnissen.
- FDA Emergency Use Authorization for PEMGARDA in immunocompromised individuals
- Coverage by Medicare, Medicaid, and major commercial health plans
- Recommendation by Infectious Disease Society of America for PEMGARDA use
- Launch of Patient Savings Program for eligible commercially insured patients
- Continued neutralizing activity against dominant SARS-CoV-2 variants
- Development of next-generation mAb candidate VYD2311 with promising early results
- Increasing COVID-19 death rates throughout 2024
- efficacy of vaccines in immunocompromised individuals
Insights
The FDA's EUA for PEMGARDA (pemivibart) marks a significant advancement in protecting immunocompromised individuals from COVID-19. This monoclonal antibody offers a important alternative for those who may not respond adequately to vaccines. The IDSA's recommendation further validates its importance in clinical practice.
The continued neutralizing activity against dominant variants KP.3.1.1 and LB.1 is particularly noteworthy, demonstrating PEMGARDA's adaptability to viral mutations. This is critical for maintaining efficacy as the virus evolves. The development of VYD2311, showing high potency against post-Omicron variants, indicates Invivyd's commitment to staying ahead of viral mutations.
However, it's important to note that while promising, long-term efficacy and safety data for PEMGARDA are still due to its recent authorization. Ongoing monitoring will be important to fully understand its real-world performance and safety profile.
Invivyd's positioning with PEMGARDA amid rising COVID-19 cases presents a significant market opportunity. The coverage by Medicare, Medicaid and major commercial insurers like UnitedHealth Care and Aetna is important for accessibility and potential revenue growth. The Patient Savings Program could further drive adoption by reducing out-of-pocket costs for eligible patients.
However, investors should consider that the EUA status means future FDA decisions could impact long-term market presence. The company's financial performance will likely be closely tied to COVID-19 trends and competitive landscape in preventative therapeutics.
The ongoing development of VYD2311 demonstrates a pipeline strategy to maintain market relevance. This diversification could mitigate risks associated with relying solely on PEMGARDA. Investors should monitor the progress of clinical trials and potential regulatory milestones for VYD2311 as indicators of future growth prospects.
- Centers for Disease Control and Prevention (CDC) reports death rate due to COVID-19 has continued to increase throughout 2024
- Immunocompromised patients at greatest risk for serious infections or even death due to COVID-19
- PEMGARDA™ available under Emergency Use Authorization (EUA) for certain immunocompromised adults and adolescents; recommended by Infectious Disease Society of Americas (IDSA) guidelines
- Covered by Medicare and Medicaid and has achieved rapid growth in commercial coverage across national and regional plans, including United Health Care, Aetna, Cigna, and Regional Blue Cross Blue Shield plans
- Continued neutralizing activity of PEMGARDA™ shown against dominant SARS-CoV-2 variants KP.3.1.1 and LB.1
WALTHAM, Mass., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, today announced a business readiness update in response to a recent increase in COVID-19 cases nationwide.
According to the Centers for Disease Control and Prevention (CDC), as of early September, the rate of death due to COVID-19 has continued to increase throughout 2024. While the CDC recommends COVID-19 vaccination for a broad population, the U.S. Food and Drug Administration (FDA) has recognized there are vulnerable individuals at high-risk of infection and that require a preventative therapeutic alternative where vaccines may not provide adequate protection.
COVID-19 is a particular threat for immunocompromised adults and adolescents with moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments because they may not mount a strong enough immune response to vaccines due to their condition. The lack of immunity can leave this community of people vulnerable to serious infection or death.
Invivyd’s PEMGARDA (pemivibart), an investigational monoclonal antibody (mAb) that has been granted Emergency Use Authorization (EUA) by the FDA for pre-exposure prophylaxis (PrEP) of COVID-19 in certain adults and adolescents (aged 12 or older weighing at least 40kg) in the U.S. with moderate-to-severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments who are unlikely to mount an adequate response to COVID-19 vaccination, is ready nation-wide to meet the demand for appropriate patients in need.
In August, the Infectious Disease Society of Americas (IDSA) updated their COVID-19 guidelines to recommend the use of PEMGARDA (pemivibart) for PrEP in moderately to severely immunocompromised adults and adolescents (aged 12 or older) at risk for progression to severe COVID-19 when predominant regional variants are susceptible to pemivibart.
“COVID-19 remains an ever-present threat, and the ramifications of infection can be disastrous, especially for those who are immunocompromised. PEMGARDA is designed to add more protection as COVID-19 vaccines alone may be insufficient or not recommended for certain immunocompromised people, leaving the most vulnerable populations at risk,” said Marc Elia, Chairman of the Invivyd Board of Directors.
Invivyd is prepared for the surge in COVID-19 with a robust supply of PEMGARDA, and the company is working to ensure access. PEMGARDA (pemivibart) is currently covered by Medicaid and Medicare, and Invivyd is in active, positive discussions with national payors to advocate for broad and equitable access to PEMGARDA for appropriate immunocompromised patients. While coverage decisions by insurers across payor segments can take time, Invivyd is focused on helping patients who are prescribed PEMGARDA to gain access as quickly as possible.
The company has launched the Invivyd Patient Savings Program (PSP), a financial assistance program for eligible commercially insured patients. The PSP may assist eligible patients by covering up to
Patients prescribed PEMGARDA (pemivibart) can find an infusion center location by visiting pemgarda.com/hcp/infusion-center-locator/.
Additionally, earlier this month, Invivyd announced continued neutralizing activity of PEMGARDA against dominant SARS-COV-2 variants KP.3.1.1 and LB.1, and attractive neutralization potency of VYD2311, a next generation mAb candidate for COVID-19 with high in vitro neutralization potency shown against post-Omicron COVID-19 variants tested to date, and other potentially favorable biophysical properties. In addition, Invivyd recently announced dosing of the first participants in a first-in-human clinical trial for VYD2311.
About PEMGARDA
PEMGARDA™ (pemivibart) is a half-life extended investigational monoclonal antibody (mAb). PEMGARDA was engineered from adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and provided evidence of clinical efficacy in a global Phase 2/3 clinical trial for the prevention and treatment of COVID-19. PEMGARDA has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1. PEMGARDA targets the SARS-CoV-2 spike protein receptor binding domain (RBD), thereby inhibiting virus attachment to the human ACE2 receptor on host cells.
PEMGARDA injection (4500 mg), for intravenous use is an investigational mAb that has not been approved, but has been authorized for emergency use by the U.S. FDA under an EUA for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
PEMGARDA is not authorized for use for treatment of COVID-19 or post-exposure prophylaxis of COVID-19. 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 vaccinations, 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.
Anaphylaxis has been observed with PEMGARDA and the PEMGARDA Fact Sheet for Healthcare Providers includes a boxed warning for anaphylaxis. The most common adverse events (all grades, incidence ≥
To support the EUA for PEMGARDA, an immunobridging approach was used to determine if PEMGARDA may be effective for pre-exposure prophylaxis of COVID-19. Immunobridging is based on the serum virus neutralizing 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 EUA. There are limitations of the data supporting the benefits of PEMGARDA. Evidence of clinical efficacy for other neutralizing human mAbs against SARS-CoV-2 was based on different populations and SARS-CoV-2 variants that are no longer circulating. Further, the variability associated with cell-based EC50 value determinations, along with limitations related to pharmacokinetic data and efficacy estimates for the mAbs in prior clinical trials, impact the ability to precisely estimate protective titer ranges. Additionally, certain SARS-CoV-2 viral variants may have substantially reduced susceptibility to PEMGARDA, and PEMGARDA may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants.
The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner. 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
About VYD2311
VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new therapeutic options for vulnerable populations, including immunocompromised people. Globally, there are millions of immunocompromised people, with an estimated 8 million in the U.S. alone, who may not adequately respond to COVID-19 vaccination, increasing their risk for severe outcomes from COVID-19.
VYD2311 was engineered from adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 3 clinical trials for both the prevention and treatment of COVID-19. The pharmacokinetic profile of VYD2311 may offer the ability to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration.
About Invivyd
Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. The company’s proprietary INVYMAB™ platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering. INVYMAB is designed to facilitate the rapid, serial generation of new monoclonal antibodies (mAbs) to address evolving viral threats. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for its first mAb in a planned series of innovative antibody candidates. Visit https://invivyd.com/ to learn more.
Cautionary Note Regarding Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “estimates,” “intends,” “potential,” “projects,” and “future” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, expectations regarding the upcoming respiratory virus season and COVID-19 landscape; the potential threat and ramifications of COVID-19 for certain immunocompromised people; the company’s beliefs regarding readiness with PEMGARDA for appropriate patients in need; the company’s progress and plans related to the commercialization of PEMGARDA, including its preparedness for the surge in COVID-19 and efforts to ensure access; the company’s ongoing research and clinical development activities, as well as future potential research and clinical development efforts; the continued in vitro neutralizing activity of PEMGARDA and VYD2311 against major SARS-CoV-2 variants; the potential of PEMGARDA as a mAb for pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents who have moderate-to-severe immune compromise; the potentially favorable biophysical properties of VYD2311 and the potential ability of VYD2311 to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration; the company’s devotion to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2; the design of the company’s INVYMAB platform approach to facilitate the rapid, serial generation of new mAbs to address evolving viral threats; and other statements that are not historical fact. The company may not actually achieve the plans, intentions or expectations disclosed in the company’s forward-looking statements and you should not place undue reliance on the company’s forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: the timing, progress and results of the company’s discovery, preclinical and clinical development activities; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the predictability of clinical success of the company’s product candidates based on neutralizing activity in nonclinical studies; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; the company’s reliance on third parties with respect to virus assay creation and product candidate testing and with respect to its clinical trials; variability of results in models used to predict activity against SARS-CoV-2 variants; whether VYD2311, pemivibart or any other product candidate is able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; how long the EUA granted by the FDA for PEMGARDA will remain in effect and whether the EUA is revoked or revised by the FDA; the company’s ability to build and maintain sales, marketing and distribution capabilities to successfully commercialize PEMGARDA; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways for authorization or approval of the company’s product candidates; the ability to maintain a continued acceptable safety, tolerability and efficacy profile of any product candidate following regulatory authorization or approval; changes in the regulatory environment; changes in expected or existing competition; the complexities of manufacturing mAb therapies; the company’s ability to leverage its INVYMAB platform approach to facilitate the rapid, serial generation of new mAbs to address evolving viral threats; any legal proceedings or investigations relating to the company; the company’s ability to continue as a going concern; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, each filed with the Securities and Exchange Commission (SEC), and in the company’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.
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Contacts:
Media Relations
(781) 208-0160
media@invivyd.com
Investor Relations
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investors@invivyd.com
FAQ
What is PEMGARDA and who is it authorized for?
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