The Food and Drug Administration has approved a new medication to protect a specific group of people who are most vulnerable to Covid.
The FDA granted emergency use authorization for Pemgarda, a monoclonal antibody infusion, for immunocompromised individuals aged 12 and above. This drug is designed to provide protection against Covid for those who may not develop a sufficient immune response post-vaccination, such as recipients of stem cell or organ transplants and cancer patients on immunosuppressive medications.
Dr. Michael Mina, chief science officer for eMed, a telehealth company, emphasized the importance of protecting this vulnerable group who may feel neglected during the ongoing pandemic.
Dr. Ziyad Al-Aly, chief of research and development at the Veterans Affairs St. Louis Healthcare System, also highlighted the significance of this development for immunocompromised individuals.
Pemgarda is expected to be available in the coming weeks, according to David Hering, CEO of Invivyd. The company is still determining the cost of the drug, with Medicare and private insurance likely to provide coverage.
The drug is administered as an infusion in healthcare settings, taking approximately an hour to complete. Common side effects include reactions at the infusion site, cold and flu symptoms, fatigue, headaches, and nausea. A small number of participants in a clinical trial experienced severe allergic reactions.
The goal is to administer the drug proactively to reduce the risk of severe Covid outcomes and minimize the chances of infection. The drug is not a treatment for active Covid cases or recent exposure.
Patients may receive the drug every three months, though the need for ongoing dosing is still under evaluation. Dr. Joseph Bailey from the Northwestern Medicine Comprehensive COVID-19 Center expressed caution regarding the drug’s full approval status and its real-world effectiveness.
Previous monoclonal antibody treatments, like Evusheld, were discontinued due to reduced effectiveness against new Covid variants. The makers of Pemgarda are prepared to target emerging variants, but the effectiveness against evolving strains remains uncertain, according to experts.
Despite the uncertainties, experts remain optimistic about the potential impact of Pemgarda in protecting vulnerable populations against Covid.
