Lagging COVID Antibody Uptake Continues To Worry US Government

Source : 'The Pink Sheet'

Two months after the coronavirus treatments were granted emergency use authorizations, uptake of Eli Lilly and Company and Regeneron Pharmaceuticals, Inc.’s COVID-19 monoclonal antibodies in the US is still limited, government officials said on a 14 January press call that articulated few ways to address the ongoing challenge.

Current utilization rates are in the 20% to 25% range, Colonel Dedre Teyhen, the deputy lead of therapeutics for Operation Warp Speed, said on the call.

The Trump administration is encouraging both patients and physicians to be more proactive in requesting and using the antibody treatments which initial clinical data suggests may prevent disease worsening and limit hospitalizations, while acknowledging more than a half-dozen factors are contributing to the lack of use –  most of which will not be resolved by the publicization strategy.

The government is also adding information on where antibodies are available around the country to its combatcovid.hhs.gov website. All locations with antibody will be required to have inventory listed on the site as of next week.

The reasons for the limited uptake are “multifactorial,” said Janet Woodcock, Warp Speed’s therapeutic lead and FDA’s principal medical advisor to the commissioner.

“We don’t have the kind of evidence people are used to,” she said noting the medicines were developed in about nine months.

Woodcock said that additional randomized controlled trial data, along with real-world evidence should eventually add to the current knowledge base but envisioned there might always be some gaps.

“I doubt we will ever get the kind of data that you get in a five-year ordinary clinical development program,” she said.

The second barrier to more antibody administration is that “health care systems are crashing,” under the latest pandemic surge and they don’t have the ability to take staff from hospitals and put them at a site where these treatments can be infused.

It “appears to be a health care resilience issue,” Teyhen added.

The situation has created a Catch-22.

“We recognize the health care system is very stressed, and it is difficult to set up new units to do this. On the other hand, if we don’t do this then the likelihood is that we’ll have even more overwhelmed hospitals and health care workers,” Woodcock said.

The logistical problems don’t end at staffing, Woodcock noted, as infectious patients can’t be treated in most existing infusion centers which treat cancer patients and others with autoimmune conditions that cannot be in close contact with COVID patients.

Plus COVID-19 testing delays may make it difficult for some patients to get the treatments early in the illness course as indicated.

Reimbursement hurdles are also still a challenge, officials said on the call. Some providers said they are still waiting for the government coding systems to be fixed so they can get paid for providing the treatments. ()

One thing that Woodcock doesn’t think is a problem, is doctors’ ability to figure out who might qualify for the drugs, she said.

“I don’t think it’s a problem of confusion about who’s high-risk. I mean, it’s probably about half of the people who get infected who are high risk.”

Woodcock said that there were some ongoing experiments to figure out how to enable getting people who are at high risk of disease progression the treatments faster and more information on this should be available in the coming weeks.

As they work to get the current supply to patients, Woodcock said Operation Warp Speed is also working to make sure the antibodies will work against new virus variants.

Preliminary data from the manufacturers indicates they believe the antibodies will work against the new UK variant, she said, and OWS is setting up research that will test the treatments against many other variants in circulant.

OWS is supporting research on a polyclonal intervention made in cows, Woodcock said, that should hopefully cover many variants.

“We’re aiming towards combinations of so-called cocktails of monoclonals because its much less likely that any given variant would escape both of them at once,” she said.

To assist sponsors developing monoclonal antibodies and other therapeutic proteins FDA released new guidance on 14 January on the proper potency assays needed to ensure that each lot produces the necessary clinical efficacy and that the potency is maintained over the product’s shelf life.

If the monoclonal antibody has multiple mechanisms of actin, multiple potency assay should be used, FDA said.

By Sarah Karlin-Smith