Hyperimmune intravenous immunoglobulin (hIVIG), derived from plasma, could improve on the efficacy of the Food and Drug Administration’s (FDA) authorised COVID-19 convalescent plasma treatment, but whether it will be clinically significant remains nebulous, based on reporting from the Manasi Vaidya, Pharma Writer for the Investigative News team at GlobalData.
In addition to several immune-focused approaches to treat COVID-19, hIVIG has been in the news following the recent launch of a Phase III COVID-19 trial led by the National Institutes of Health (NIH) to evaluate this approach. Takeda Pharmaceuticals, Emergent Biosolutions, Grifols and CSL Behring are supplying the hIVIG for the study.
Vaidya states, “Unlike convalescent plasma, hIVIG is a plasma product that is a standardised and concentrated mixture of polyclonal antibodies against the SARS-CoV-2. hIVIG contains a known high titer of neutralising antibodies so there is strong scientific rationale for hIVIG being more effective than convalescent plasma.”
The FDA awarded an emergency use authorization (EUA) for convalescent plasma, or plasma derived from individuals infected with COVID-19, on 23 August. However, experts are awaiting clinical evidence, in combination with standard drugs like Gilead Sciences’ Veklury (remdesivir) to understand the magnitude of impact of hIVIG.
Vaidya notes, “In comparison to the closely related approach of monoclonal antibodies (mAb), manufacturing hIVIG is not as straightforward since it is dependent on plasma supplies and may require logistical support if found effective. Monoclonal antibodies received widespread attention when Regeneron Pharmaceuticals’ mAb cocktail was used to treat US President Donald Trump. EUA applications for mAbs from Eli Lilly and Regeneron are currently being assessed by the FDA.
“Studying hIVIG in clinical trials may also be challenging since COVID-19 patients can currently access convalescent plasma outside of a study. However, there is physician enthusiasm to conduct these randomised studies to provide definitive information on who may benefit from this approach.”