The drug offers immediate post-exposure protection against the virus and will serve as a counterpart to the vaccine during its early phases.
Grifols, a Spanish pharmaceutical and chemical manufacturer, announced on Jan. 18, 2021 that it has initiated a clinical trial in Spain to evaluate a new COVID-19 drug based on its immunoglobulin, Gamunex-C, and antibodies from plasma donors who have recovered from the disease.
According to a company press release, the drug offers immediate post-exposure protection against the virus and will serve as a counterpart to the vaccine during its early phases. Additionally, the new drug has the potential to contain COVID-19 outbreaks in areas where vaccination measures haven’t started or are still underway.
“[The drug] is easy to refrigerate while its subcutaneous administration facilitates its distribution and use in any doctor’s office, avoiding hospitalization,” said Dr. Antonio Páez, medical director at Grifols, in the press release. “If the new therapy’s efficacy is confirmed, it could be administered to people who test positive for the virus through PCR and antigen tests in hospitals and primary care offices.”
Source: Grifols
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.