FDA Could Soon Limit Use of Only Drug for COVID Prevention - i.e.,Pemivibart may have reduced activity against growing variant KP.3.1.1

[cujoe]

As an update to several earlier posts about the use of Pemivibart for COVID. It seems the FDA is about to limit its use to only as a pre-exposure prophylaxis agent for COVID-19 in immunocompromised patients.

Here is the MedPage article dated August 27, 2024 in full:

* * *

MedPage Today - Infectious Disease - COVID-19

FDA Could Soon Limit Use of Only Drug for COVID Prevention — Pemivibart may have reduced activity against growing variant KP.3.1.1, agency warns, by Katherine Kahn, Staff Writer, MedPage Today, August 27, 2024

Pemivibart (Pemgarda) should only be used for pre-exposure prophylaxis of COVID-19 in immunocompromised patients when the combined national frequency of SARS-CoV-2 variants with substantially reduced susceptibility to the drug is less than or equal to 90%, the FDA announced on Monday.

The agency revised the emergency use authorization (EUA) for the long-acting monoclonal antibody based on available information about SARS-CoV-2 variant susceptibility to pemivibart and national variant frequency, Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research, wrote in a letter to pemivibart's manufacturer, Invivyd.

"FDA is proactively incorporating this Limitation of Authorized Use in the event that variants with substantially reduced susceptibility to Pemgarda reach this threshold," Cavazzoni wrote.

KP.3 and KP.3.1.1 are now the most frequently reported SARS-CoV-2 variants circulating in the U.S. at this time. Based on CDC's Nowcast estimates from August 17, KP.3 comprises an estimated 17% of circulating variants in the U.S. and KP.3.1.1 comprises 37%, the latter up from 23% over the 2 weeks prior.

Although pemivibart is likely to retain adequate neutralization activity against the KP.3 variant, KP.3.1.1 may have substantially reduced susceptibility, the FDA warned.

The FDA issued the initial EUA for pemivibart in March of this year as COVID-19 pre-exposure prophylaxis in individuals ages 12 years and older (weighing at least 40 kg) who are not currently infected with SARS-CoV-2 and who have moderate-to-severe immune compromise due to a medical condition or immunosuppressive treatments.

Currently, pemivibart is the only available monoclonal antibody for the prevention of COVID-19 in patients at risk for severe disease.

In addition to the revision of the EUA, the FDA also revised the authorized fact sheets for healthcare providers to inform about the increased risk of developing COVID-19 for patients exposed to SARS-CoV-2 variants with reduced susceptibility to pemivibart. Detailed neutralization data can be found in the revised fact sheet.

The FDA recommended that healthcare providers discuss this risk with patients receiving pre-exposure prophylaxis and advise patients who develop signs or symptoms of COVID-19 to test for SARS-CoV-2 infection and promptly seek medical attention, including starting treatment for COVID-19, as appropriate, if they test positive.

Several COVID-19 treatments -- nirmatrelvir/ritonavir (Paxlovid), remdesivir (Veklury), and molnupiravir (Lagevrio) -- are expected to work against currently circulating variants, and are approved or authorized to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease.

Katherine Kahn is a staff writer at MedPage Today, covering the infectious diseases beat. She has been a medical writer for over 15 years.

* * *

Here are links to the MedPage Article - and to a PDF download of the FDA letter to pemivibart's manufacturer, Invivyd, the CDC's COVID-19 Treatment Clinical Care for Outpatients Guide, and one to the CDC's COVID very detailed (for US only) tracker - all mentioned and hyperlinked in MedPage article:

FDA Could Soon Limit Use of Only Drug for COVID Prevention — Pemivibart may have reduced activity against growing variant KP.3.1.1, agency warns, by Katherine Kahn, Staff Writer, MedPage Today, August 27, 2024

medpagetoday.com/infectious...

FDA letter to Invivyd, dated 2024 August 26:

fda.gov/media/177068/download

CDC's COVID tracker

covid.cdc.gov/covid-data-tr...

Stay Safe & Well,

cujoe

[wmay13241]

Is the 24-25 covid shot effective against the KP.3.1.1 variant?

[Pinecrest in reply to wmay13241]

Yes.

“Will future vaccines work against KP.3.1.1?

On Aug. 22, the FDA greenlit a new COVID-19 vaccine for the 2024-2025 respiratory disease season, and it was designed to target KP.2. Since KP.2 is a close relative of KP.3.1.1, the new shot is likely to work fairly well against the currently circulating variant. These updated shots should be available to people of all ages in the coming weeks, according to the manufacturers, Pfizer-BioNTech and Moderna—good timing, with lots of virus still going around.

Novavax is also seeking regulatory approval of a shot meant to target JN.1, which would likely also provide some protection against its descendant KP.3.1.1.”

From Time. Com