Invivyd Receives HCPCS Reimbursement Codes and FDA Authorization for PEMGARDA: A Breakthrough Prophylaxis Against COVID-19
WALTHAM, Mass. March 22, 2024 - Invivyd, Inc. (Nasdaq: IVVD), a renowned biopharmaceutical company committed to safeguarding the vulnerable population against severe viral infectious diseases, announced today a significant milestone for PEMGARDA (pemivibart). Previously known as VYD222, this half-life extended monoclonal antibody (mAb) has been granted emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older) who suffer from moderate-to-severe immune compromise due to specific medical conditions or receipt of certain immunosuppressive medications or treatments. Importantly, these individuals are unlikely to develop an adequate immune response to COVID-19 vaccination. Furthermore, it is essential that these recipients are not currently infected with or have had recent exposure to SARS-CoV-2.
This remarkable achievement by Invivyd brings hope to millions of immunocompromised individuals who have been struggling to protect themselves from the ongoing threat of COVID-19. The EUA demonstrates the confidence and trust of the FDA in Invivyd’s groundbreaking therapeutic solution.
In addition to the FDA authorization, Invivyd has also received reimbursement codes from the U.S. Centers for Medicare & Medicaid Services (CMS) for PEMGARDA under the Healthcare Common Procedure Coding System (HCPCS). This commendable feat further underscores the value and significance of this innovative prophylactic treatment.
PEMGARDA’s mechanism of action revolves around its ability to neutralize the SARS-CoV-2 virus by specifically targeting the spike protein, thereby impeding viral entry and replication within the body. With an extended half-life, PEMGARDA offers an extended duration of protection, reducing the frequency of required administrations and enhancing patient convenience.
Dr. John Davis, the CEO of Invivyd, expressed his enthusiasm for this significant milestone, stating, We are thrilled to receive the EUA from the FDA for PEMGARDA, as it represents a significant advancement in our fight against COVID-19. This prophylactic treatment holds immense potential for individuals with compromised immune systems, allowing them to better protect themselves from the virus.
The granting of reimbursement codes by CMS for PEMGARDA is a crucial step in ensuring access to this groundbreaking therapy for those who need it the most. These codes enable healthcare providers to bill insurance companies for the cost of the treatment, potentially making it more accessible and affordable for patients.
Invivyd remains committed to advancing the development of novel therapies to combat various infectious diseases and protect the most vulnerable populations. The company’s dedication to research and innovation, coupled with this recent achievement, establishes them as a leader in the field and gives hope to individuals at an increased risk of severe COVID-19.
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