By Dean Seal
Invivyd said regulators are ending emergency use authorization for its Covid-19 prevention medication, Pemgarda.
The Food and Drug Administration sent Invivyd a notice of termination, with the designation set to end June 29 of next year.
The Department of Health and Human Services is winding down emergency authorizations related to Covid-19 for drugs and biological products, as well as medical devices, after concluding that the circumstances for those authorizations had abated.
Pemgarda is an investigational antibody authorized in March 2024 for prevention of Covid-19 in adults and adolescents with moderate-to-severe immune compromise due to certain medical conditions or their use of immunosuppressive medications.
Marc Elia, Invivyd's board chairman, said the end of the formal emergency for Covid-19 products was "in many ways overdue," as the designation isn't the same as a product approval.
"We feel as though a full approval of Pemgarda is well-warranted at this time by the totality of demonstrated safety and efficacy data," he said.
Invivyd is in active dialogue with FDA on next steps.
Write to Dean Seal at dean.seal@wsj.com