The FDA has greenlighted a new medication to protect those most at risk from COVID-19.
According to the regulatory authority, individuals with impaired immune systems aged 12 and above can now get Pemgarda, a monoclonal antibody infusion, as an emergency treatment. If a person’s immune system does not react well to the COVID-19 vaccine, this medication can help protect them against the virus. Anyone whose immune system has been compromised due to cancer treatment, stem cell transplants, or organ donation should also be aware of this.
Invivyd CEO David Hering has stated that Pemgarda’s release is scheduled for the next two weeks. Mr. Hering claims that the drug’s price is now being considered by the corporation. He expects it to be covered by Medicare and private insurance.
Delivering the medicine through an infusion in healthcare institutions and other similar locations usually takes about an hour. Nausea, headaches, exhaustion, infusion site responses, and flu-like symptoms were among the clinical trial’s most frequently reported adverse effects. Anaphylaxis, a life-threatening allergic event, occurred in just four of the 623 study participants.
Hering said their goal is to provide the medicine before exposure to the virus so that there is less chance of severe problems from COVID-19 and the virus itself. Anyone who is infected with or has recently come into contact with the COVID-19 virus should not use Pemgarda.
Mr. Hering claims that people can choose to have the medication every three months. According to pulmonologist Dr. Joseph Bailey of the Northwestern Medicine Comprehensive COVID-19 Center, the necessity for continuous supplemental medication dosages is unclear.
Complete clearance for Pemgarda is still pending. The study is still ongoing, says Dr. Bailey. After reviewing information on titers, which quantify antibodies, the agency authorized the medicine. Thus, the precise efficacy of the drug in avoiding infections in the actual world cannot be determined at this time.
Due to their diminishing efficacy against new COVID types, earlier monoclonal antibody therapies like Evusheld were removed from the market. Mr. Hering says the Pemgarda production firm is getting ready to zero in on new variants as they emerge. University of California, San Francisco infectious disease expert Dr. Peter Chin-Hong is unsure what may happen if the virus evolves.
Despite this, professionals are still bullish.
