The regulator’s restrictions come as the U.S. is experiencing a surge in cases. Invivyd also announced updated Phase III data for Pemgarda, touting an 84% relative reduction in symptomatic COVID-19.
The FDA on Monday renewed the emergency use authorization for Invivyd’s pre-exposure prophylactic antibody Pemgarda (pemivibart) for COVID-19, but with a notable restriction on its use depending on the prevalence of virus variants.
The regulator allows the use of the prophylactic “only when the combined national frequency of variants with substantially reduced susceptibility to Pemgarda is less than or equal to 90%,” according to its letter to Invivyd. Pemgarda is also not authorized for the treatment of COVID-19 or for post-exposure prophylaxis, according to the FDA, which emphasized that the monoclonal antibody is not a substitute for vaccination.
Initially granted emergency authorization in February 2020, Pemgarda is a monoclonal antibody with an extended half-life. It works by targeting the spike protein receptor binding domain, preventing the SARS-CoV-2 virus from attaching to and entering its target host cells. The FDA reissued Pemgarda’s emergency use authorization in March 2024 but has not yet approved the prophylactic injection.
On Tuesday, Invivyd published findings from the ongoing Phase III CANOPY study demonstrating an 84% relative risk reduction in symptomatic COVID-19 after prophylaxis with Pemgarda compared with placebo. The effect was highly statistically significant, with a p-value of 0.000061, according to the company.
The FDA included these findings in its updated Fact Sheet for Pemgarda, informing healthcare providers of the “clinically meaningful protection” associated with Pemgarda against different circulating SARS-CoV-2 variants, Mark Wingertzahn, Invivyd’s senior vice president of clinical development and medical affairs, said in a statement.
Still, CANOPY might not accurately have captured the current COVID-19 variant landscape. The study was conducted between September 2023 and March 2024, when the XBB and JN.1 variants were highly predominant, according to Invivyd.
Currently, the Centers for Disease Control and Prevention (CDC) estimates that the KP.3 and KP.3.1.1 are responsible for the recent surge in cases, accounting for 16.8% and 36.8% of infections in the U.S., respectively.
The new restrictions on Pemgarda’s use come as the U.S. is experiencing a COVID-19 surge, with case numbers rapidly rising in at least 25 states, according to the CDC. The estimated reproduction rate for the virus also indicates that infections are becoming more prevalent across the country, on average, while wastewater analysis shows that the activity of SARS-CoV-2 is “very high.”
Last week, in an effort to combat this surge, the FDA approved updated mRNA vaccines from Moderna and Pfizer/BioNTech, which are specifically designed to elicit immune protection against the virus’ KP.2 variant.
