FDA warns that emerging Omicron subvariant could make Evusheld obsolete

 AstraZeneca’s Covid-19 pre-exposure prophylactic Evusheld has managed to remain relevant for immunocompromised and other patients when many of its therapeutic peers haven’t with each new Omicron subvariant.

But that win streak may slowly come to a close as the FDA told healthcare providers on Monday that one of the emerging subvariants, BA.4.6, renders Evusheld almost completely useless.

Nationally, BA.4.6 currently makes up about 13% of new cases, compared to just 1% of cases at the beginning of July, according to the CDC. But in some regions, like in Iowa, Missouri, Kansas and Nebraska, the BA.4.6 subvariant makes up more than 20% of all Covid-19 cases.

AstraZeneca’s spokesperson told Endpoints News in a statement that in vitro data conducted by an FDA lab “showed that Evusheld is unlikely to be active against BA.4.6, which currently represents 6.2% of infections globally and growing slowly; it is not expected to become a dominant strain.”

Evusheld remains active against the dominant variant, BA.5, the spokesperson added, noting that the prophylactic “should continue to provide protection to the vast majority of intended recipients.”

If BA.4.6 spreads more nationally, and Evusheld can no longer be used, the blow would be a big one for for AstraZeneca, which saw the intramuscular injection pull in $914 million in the first half of 2022, and another $135 million last year.

If another subvariant takes over or BA.5 remains dominant, and Evusheld holds up, the commercial market awaits as federal funds dry up. HHS previously said that the remaining federal supply of Evusheld (about 750,000 courses of the 1.5 million ordered remain) could be gone by as soon as early 2023.

US expects to soon run out of government Covid-19 funds for vaccines, treatments

FDA on Monday also updated the Evusheld fact sheet to broaden the patient population that may benefit from it, especially among people with blood cancers regardless of treatment status, the spokesperson added.

https://endpts.com/another-one-bites-the-dust-fda-warns-that-emerging-omicron-subvariant-could-make-evusheld-obsolete/