Invivyd, Inc., a biopharmaceutical company specializing in combating severe viral infections, has disclosed its intention to seek emergency use authorization from the U.S. Food and Drug Administration for pemivibart. This treatment is aimed at individuals with mild to moderate symptomatic COVID-19 who are immunocompromised, utilizing a swift immunobridging pathway. This strategy builds on Invivyd's prior success in obtaining EUA for PEMGARDA™ (pemivibart) for COVID-19 pre-exposure prophylaxis (PrEP) in certain immunocompromised individuals and aligns with FDA principles.

The rapid pathway draws on data from the Phase 2/3 clinical trial (STAMP) of adintrevimab, a prototype monoclonal antibody (mAb) for COVID-19 treatment, and ongoing clinical trials of pemivibart for COVID-19 PrEP. The proposed EUA request aims to address the urgent treatment needs of immunocompromised individuals in the U.S. who lack suitable alternatives. Following the submission of the EUA request, Invivyd plans to conduct a streamlined clinical trial focusing on safety, pharmacokinetics (PK), and clinical virology confirmation.

Marc Elia, Chairman of the Invivyd Board of Directors, expressed satisfaction in aligning with the FDA to address critical medical needs among immunocompromised individuals facing symptomatic COVID-19. He highlighted the company's previous success with monoclonal antibodies (mAbs) targeting the SARS-CoV-2 spike protein's receptor binding domain (RBD) and its commitment to both prevention and treatment efforts.

Mark Wingertzahn, Senior Vice President of Clinical Development and Medical Affairs, emphasized the urgency of the initiative, citing the significant risk COVID-19 poses to immunocompromised patients and the efficacy of infused antibody therapies in such contexts.

Observational studies underscore the disproportionate impact of COVID-19 on immunocompromised individuals, warranting alternative treatment options like monoclonal antibodies alongside small molecule therapies.

Brian Koffman, Co-Founder, Executive Vice President, and Chief Medical Officer of the CLL (Chronic Lymphocytic Leukemia) Society, emphasized the importance of new monoclonal antibody treatments, particularly for vulnerable populations who may not benefit from existing options.

Invivyd reaffirmed its revenue guidance for 2024, projecting $150-$200 million in PEMGARDA net product revenue. However, this guidance did not anticipate potential sales for COVID-19 treatment or the need for additional inventory to meet patient demand.

PEMGARDA™ (pemivibart) is an investigational monoclonal antibody (mAb) engineered from adintrevimab, demonstrating efficacy in global Phase 2/3 trials for both COVID-19 prevention and treatment. It targets the SARS-CoV-2 spike protein's receptor binding domain (RBD) and has shown neutralizing activity against major variants.

The emergency use of PEMGARDA is authorized for individuals aged 12 and older with moderate-to-severe immune compromise for COVID-19 PrEP, with considerations for safety and potential adverse events outlined in product information.

In conclusion, Invivyd's pursuit of EUA for pemivibart reflects a commitment to addressing the urgent treatment needs of immunocompromised individuals facing symptomatic COVID-19, building upon the success of prior prevention efforts.

 

Source: globenewswire.com

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